Individualized Drug Treatment for Treating Patients With Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT00276744 |
Recruitment Status :
Terminated
(Because there was no longer an active laboratory component to this study.)
First Posted : January 13, 2006
Results First Posted : August 27, 2018
Last Update Posted : October 24, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | January 12, 2006 | ||||
First Posted Date ICMJE | January 13, 2006 | ||||
Results First Submitted Date ICMJE | February 27, 2018 | ||||
Results First Posted Date ICMJE | August 27, 2018 | ||||
Last Update Posted Date | October 24, 2018 | ||||
Study Start Date ICMJE | October 2005 | ||||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
6-month Overall Survival [ Time Frame: 6 months ] Percentage of patients survived at 6 months for patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model
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Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Individualized Drug Treatment for Treating Patients With Pancreatic Cancer | ||||
Official Title ICMJE | A Feasibility Study for Individualized Treatment of Patients With Advanced Pancreatic Cancer | ||||
Brief Summary | RATIONALE: Treating tumor tissue in the laboratory with different drugs may help doctors find the best drug for treating individual patients with pancreatic cancer. PURPOSE: This phase II trial is studying an individualized drug treatment selection process, based on laboratory results, for treating patients with pancreatic cancer that can be removed by surgery. |
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Detailed Description | OBJECTIVES:
OUTLINE:
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Pancreatic Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Arm 1
PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuvant treatment based on physician discretion and will be followed until disease progression. Capecitabine 1,5 mmol/kg Oral gavage 1- 5 days x 2 weeks Cetuximab 500 mg IP Twice a week x 2 weeks Docetaxel 20 mg/kg IV Once at week x 4 weeks Erlotinib 75 mg/kg IP 1-5 days x 2 weeks Gemcitabine 100 mg/kg IP Twice a week x 4 weeks Irinotecan 50 mg/kg IV Twice a week Mitomycin C 5 mg/kg IP One dose Rapamycin 4 mg/kg IP 1-5 days x 2 weeks PART B: At the time of progression, patients will be evaluated for Part B of the study and treated with the drug selected in Part A as the most active using approved doses and schedules of administration. Interventions:
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Publications * | Villarroel MC, Rajeshkumar NV, Garrido-Laguna I, De Jesus-Acosta A, Jones S, Maitra A, Hruban RH, Eshleman JR, Klein A, Laheru D, Donehower R, Hidalgo M. Personalizing cancer treatment in the age of global genomic analyses: PALB2 gene mutations and the response to DNA damaging agents in pancreatic cancer. Mol Cancer Ther. 2011 Jan;10(1):3-8. doi: 10.1158/1535-7163.MCT-10-0893. Epub 2010 Dec 6. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
249 | ||||
Original Enrollment ICMJE | Not Provided | ||||
Actual Study Completion Date ICMJE | April 2010 | ||||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Part A Inclusion Criteria
Part B Inclusion Criteria
WBC > 3,500 cells/mm3 ANC > 1,500 cells/mm3 Platelets > 100,000 cells/mm3 Hemoglobin ≥ 9 g/dl Serum creatinine 2 mg/dl Bilirubin 2 mg/dL ALT, AST, and alkaline phosphatase 5 times the upper limit of normal Exclusion criteria
4. Patients who have had any previous surgery, excluding minor procedures, dental work, skin biopsy, etc. within 4 weeks of enrollment. 5. Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications when treated with chemotherapy. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. 6. Active infections. 7. History of another neoplasm except for non-metastatic, nonmelanoma skin cancers, < 5 years prior to enrollment. 8. Unable to provide informed consent. 9. Treatment with chemotherapy within 30 days of day 1 treatment. 10. Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy (except alopecia). 11. Pregnant women are excluded from this study because the effects of the chemotherapy agents to be tested on the developing fetus are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breast feeding should be discontinued if the mother is treated with the drug. 12. Patients must not have documented history of clinically significant cardiovascular disease including myocardial infarction (within 12 months prior to randomization), unstable angina, grade II or greater peripheral vascular disease, uncontrolled congestive heart failure or uncontrolled hypertension (SBP>170, DBP>95). 13. Patients with non informative xenograft data including patients whose tumors do not take in the mice, who progress before mice data is available or whose tumors do not respond to any of the selected agents. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 120 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00276744 | ||||
Other Study ID Numbers ICMJE | J0507 P30CA006973 ( U.S. NIH Grant/Contract ) CDR0000455000 05-04-14-02 ( Other Identifier: JHM IRB ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||
Original Responsible Party | Not Provided | ||||
Current Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||
Verification Date | October 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |