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Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00889187
Recruitment Status : Terminated (Excess toxicity was identified intraoperatively)
First Posted : April 28, 2009
Results First Posted : July 14, 2017
Last Update Posted : May 11, 2018
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Harvey Mamon, MD, PhD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Radiation: Neoadjuvant Short-Course Photon Radiation
Drug: Capecitabine
Enrollment 10
Recruitment Details Participants enrolled from Dec 2009 and Sep 2011.
Pre-assignment Details  
Arm/Group Title Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine Phase II: Photon Rad (MTD)+Capecitabine
Hide Arm/Group Description

Neoadjuvant Short-Course Photon Radiation:

At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Neoadjuvant Short-Course Photon Radiation:

At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Neoadjuvant Short-Course Photon Radiation:

At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Neoadjuvant Short-Course Photon Radiation:

Phase II participants received the radiation regimen established in the Phase I study (MTD).

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Period Title: Overall Study
Started 3 3 4 0
Completed 3 3 4 0
Not Completed 0 0 0 0
Arm/Group Title All Phase I: Photon Rad+Capecitabine
Hide Arm/Group Description

Neoadjuvant Short-Course Photon Radiation:

All Phase I participants received the radiation regimen according to the established dose escalation schedule.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
62.6
(57 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I]
Hide Description Neoadjuvant short-course photon radiation therapy MTD in combination with capecitabine 825 mg/m2 orally BID for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If none of 3 initial patients or only 1 of 6 patients have a DLT on dose level 3 then 6 additional patients are treated at this dose. If during this expansion, the rate of DLT exceeds 30% then the next lower dose level is declared the MTD. If no DLTs are observed, the MTD is not reached.
Time Frame within 3 weeks of the start of chemoradiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all treated patients.
Arm/Group Title All Phase I: Photon Rad+Capecitabine
Hide Arm/Group Description:

Neoadjuvant Short-Course Photon Radiation:

All Phase I participants received the radiation regimen according to the established dose escalation schedule.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Gy per fraction
NA [1] 
[1]
The study was closed early due to unexpected intraoperative complications. No patients developed a pre-specified DLT in the 10 treated patients. The MTD was not established.
2.Primary Outcome
Title Dose Limiting Toxicity (DLT) [Phase I]
Hide Description DLT occurring within 3 weeks of the start of chemoradiation therapy was defined as: Grade 3 non-hematologic or hematologic toxicity requiring interruption of >7 days (d) of chemo or >3d chemoradiation; Grade 4 non-hematologic; Grade 4 neutropenia or thrombocytopenia; Treatment-related death; Delays in surgery >3 weeks due to treatment-related toxicity. A 30% increase in any surgical complication rate beyond those previously established rates (readmission rate: 16%; pancreatic fistula/intra-abdominal abscess/infection rate: 27%, major intra-abdominal bleeding requiring return to OR: 1.6%, delayed gastric emptying: 4.4%, and superficial wound infection rate: 8%) was also considered a DLT.
Time Frame within 3 weeks of the start of chemoradiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all treated patients.
Arm/Group Title Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
Hide Arm/Group Description:

Neoadjuvant Short-Course Photon Radiation:

At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Neoadjuvant Short-Course Photon Radiation:

At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Neoadjuvant Short-Course Photon Radiation:

At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Participants Analyzed 3 3 4
Measure Type: Number
Unit of Measure: patients with DLT
0 0 0
3.Primary Outcome
Title Grade 3-5 Toxicity Rate [Phase II]
Hide Description All Grade 3-5 events based on CTCAEv3 related to the accelerated dose (attribution possible, probable, definite) as reported on case report forms.
Time Frame within 3 weeks of the start of chemoradiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Arm/Group Title Experimental: Phase II: Photon Rad (MTD)+Capecitabine
Hide Arm/Group Description:

Phase II participants received the radiation regimen established in the Phase I study (MTD).

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Local Recurrence Rate [Phase II]
Hide Description Local recurrence rate is defined as the proportion of patients with evidence of tumor recurrence within the radiation field based on RECIST criteria. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.
Hide Outcome Measure Data
Hide Analysis Population Description
The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Arm/Group Title Experimental: Phase II: Photon Rad (MTD)+Capecitabine
Hide Arm/Group Description:

Phase II participants received the radiation regimen established in the Phase I study (MTD).

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pathologic Response Rate [Phase II]
Hide Description Pathologic response rate is the proportion of patients with the pathologic specimen absent any viable tumor cell. Pathological review of the pancreaticoduodenectomy specimen will be performed according to the AJCC Staging Classification, 6th edition. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist.
Time Frame Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Arm/Group Title Experimental: Phase II: Photon Rad (MTD)+Capecitabine
Hide Arm/Group Description:

Phase II participants received the radiation regimen established in the Phase I study (MTD).

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Progression-Free Survival (PFS) [Phase II]
Hide Description Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients alive whose disease had not progressed are censored at date of last disease evaluation
Time Frame Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.
Hide Outcome Measure Data
Hide Analysis Population Description
The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Arm/Group Title Experimental: Phase II: Photon Rad (MTD)+Capecitabine
Hide Arm/Group Description:

Phase II participants received the radiation regimen established in the Phase I study (MTD).

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Surgical Morbidity Rate [Phase II]
Hide Description The proportion of patients experienced any grade 3-4 adverse event based on CTCAEv3 related to the surgery (attribution possible, probable, definite) as reported on case report forms.
Time Frame Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Arm/Group Title Experimental: Phase II: Photon Rad (MTD)+Capecitabine
Hide Arm/Group Description:

Phase II participants received the radiation regimen established in the Phase I study (MTD).

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Surgical Mortality Rate [Phase II]
Hide Description The proportion of patients with a death related to the surgery (CTCAEv3 attribution possible, probable, definite).
Time Frame Assessed up to 30 days after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Arm/Group Title Experimental: Phase II: Photon Rad (MTD)+Capecitabine
Hide Arm/Group Description:

Phase II participants received the radiation regimen established in the Phase I study (MTD).

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were assessed continuously up to 3 weeks from the start of chemoradiation therapy.
Adverse Event Reporting Description Serious AEs: AE that results in death; is life-threatening; requires or prolongs inpatient hospitalization; is disabling; is a congenital anomaly or birth defect; is medically significant or requires medical or surgical intervention to prevent one of the above outcomes. Other AEs: Remaining AEs (maximum grade by toxicity type) without regard to treatment attribution.The hemorrhage/bleeding-other case was gastrointestinal (GI) hemorrhage; no further data is available to specify infection-other.
 
Arm/Group Title Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
Hide Arm/Group Description

Neoadjuvant Short-Course Photon Radiation:

At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Neoadjuvant Short-Course Photon Radiation:

At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

Neoadjuvant Short-Course Photon Radiation:

At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.

Chemotherapy:

Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.

Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation.

All-Cause Mortality
Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   2/3 (66.67%)   0/4 (0.00%) 
Gastrointestinal disorders       
Nausea  1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%) 
Diarrhea  1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%) 
Hemorrhage/Bleeding-Other  1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Vomiting  1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%) 
Infections and infestations       
Infection-Other  1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Investigations       
Lymphopenia  1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   4/4 (100.00%) 
Blood and lymphatic system disorders       
Hemoglobin  1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%) 
Gastrointestinal disorders       
Abdomen, pain  1  1/3 (33.33%)  2/3 (66.67%)  2/4 (50.00%) 
Constipation  1  0/3 (0.00%)  1/3 (33.33%)  3/4 (75.00%) 
Diarrhea w/o prior colostomy  1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Distention/bloating, abdominal  1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%) 
Nausea  1  1/3 (33.33%)  3/3 (100.00%)  3/4 (75.00%) 
Perforation, cecum  1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Stomach, pain  1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Vomiting  1  1/3 (33.33%)  1/3 (33.33%)  2/4 (50.00%) 
General disorders       
Fatigue  1  1/3 (33.33%)  3/3 (100.00%)  3/4 (75.00%) 
Fever w/o neutropenia  1  2/3 (66.67%)  0/3 (0.00%)  0/4 (0.00%) 
Pain-other  1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Investigations       
Alkaline phosphatase  1  1/3 (33.33%)  0/3 (0.00%)  2/4 (50.00%) 
ALT, SGPT  1  1/3 (33.33%)  0/3 (0.00%)  3/4 (75.00%) 
AST, SGOT  1  1/3 (33.33%)  0/3 (0.00%)  2/4 (50.00%) 
Bilirubin  1  1/3 (33.33%)  0/3 (0.00%)  2/4 (50.00%) 
Leukocytes  1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%) 
Lymphopenia  1  2/3 (66.67%)  2/3 (66.67%)  4/4 (100.00%) 
Platelets  1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%) 
Weight loss  1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  2/3 (66.67%)  1/3 (33.33%)  2/4 (50.00%) 
Hypercalcemia  1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%) 
Hyperglycemia  1  1/3 (33.33%)  2/3 (66.67%)  1/4 (25.00%) 
Hyperkalemia  1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%) 
Hypernatremia  1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%) 
Hypoalbuminemia  1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Hypoglycemia  1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%) 
Hyponatremia  1  2/3 (66.67%)  0/3 (0.00%)  1/4 (25.00%) 
Hypophosphatemia  1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back, pain  1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%) 
Psychiatric disorders       
Anxiety  1  0/3 (0.00%)  1/3 (33.33%)  3/4 (75.00%) 
Insomnia  1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%) 
Renal and urinary disorders       
Urine color  1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%) 
Dry skin  1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%) 
Pruritus/itching  1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%) 
Rash/desquamation  1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Harvey Mamon, MD, PhD
Organization: Brigham and Women's Hospital / Dana Farber Cancer Institute
Phone: 617-732-8564
EMail: HMAMON@LROC.HARVARD.EDU
Layout table for additonal information
Responsible Party: Harvey Mamon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00889187     History of Changes
Other Study ID Numbers: 08-375
First Submitted: April 27, 2009
First Posted: April 28, 2009
Results First Submitted: April 14, 2017
Results First Posted: July 14, 2017
Last Update Posted: May 11, 2018