Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073983
Recruitment Status : Completed
First Posted : December 11, 2003
Results First Posted : March 12, 2012
Last Update Posted : March 12, 2012
Sponsor:
Information provided by:
Sarcoma Alliance for Research through Collaboration

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Interventions Biological: filgrastim
Biological: pegfilgrastim
Drug: docetaxel
Drug: gemcitabine hydrochloride
Genetic: microarray analysis
Other: laboratory biomarker analysis
Other: pharmacokinetic study
Enrollment 54
Recruitment Details Recruitment period began October 4, 2006 and was completed May 12, 2009. There were 11 SARC (Sarcoma Alliance for Research through Collaboration) sites participating. SARC sites are primarily academic institutions with Sarcoma programs.
Pre-assignment Details  
Arm/Group Title Combination Chemotherapy
Hide Arm/Group Description Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
Period Title: Overall Study
Started 54
Completed 53 [1]
Not Completed 1
Reason Not Completed
not evaluable             1
[1]
One patient in the chondrosarcoma subtype was not evaluable.
Arm/Group Title Combination Chemotherapy
Hide Arm/Group Description Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
<=18 years
3
   5.6%
Between 18 and 65 years
42
  77.8%
>=65 years
9
  16.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
43  (19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
21
  38.9%
Male
33
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
1.Primary Outcome
Title Objective Response Rate
Hide Description Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.
Time Frame After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.
Arm/Group Title Ewing's Sarcoma Osteosarcoma Chondrosarcoma
Hide Arm/Group Description:
Combination chemotherapy
Combination Chemotherapy
Combination chemotherapy
Overall Number of Participants Analyzed 14 14 25
Measure Type: Number
Unit of Measure: participants
6 5 14
2.Secondary Outcome
Title Time to Progression
Hide Description Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria.
Time Frame post-cycle 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not completed. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.
Arm/Group Title Ewing's Sarcoma Osteosarcoma Chondrosarcoma
Hide Arm/Group Description:
Combination chemotherapy
Combination Chemotherapy
Combination chemotherapy
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Toxicity as Assessed by NCI CTCAE v3.0
Hide Description Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued.
Time Frame Throughout the study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.
Arm/Group Title Ewing's Sarcoma Osteosarcoma Chondrosarcoma
Hide Arm/Group Description:
Combination chemotherapy
Combination Chemotherapy
Combination chemotherapy
Overall Number of Participants Analyzed 14 14 25
Measure Type: Number
Unit of Measure: participants
Toxicity 4 3 5
No Toxicity 10 11 20
4.Secondary Outcome
Title Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study
Hide Description Blood samples for the determination of gemcitabine (and its metabolite dFdU) will be obtained prior to infusion, at 75 and 85 minutes (steady state), and 95 105 and 120 minutes, after the start of the 90 minute infusion on day 1 and day 8 of cycle 1. On day 8, docetaxel pharmacokinetics will be performed prior to infusion, 55 minutes (5 minutes prior to the end of infusion), 30 minutes post infusion, 5 hr and 24hr post infusion.
Time Frame Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
There were insufficent samples obtained to analyze pharmacokinetics.
Arm/Group Title Ewing's Sarcoma Osteosarcoma Chondrosarcoma
Hide Arm/Group Description:
Combination chemotherapy
Combination Chemotherapy
Combination chemotherapy
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 4 years, 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combination Chemotherapy
Hide Arm/Group Description Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
All-Cause Mortality
Combination Chemotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Combination Chemotherapy
Affected / at Risk (%) # Events
Total   12/53 (22.64%)    
Blood and lymphatic system disorders   
elevated WBC  1  1/53 (1.89%)  1
anemia  1  1/53 (1.89%)  1
Cardiac disorders   
pericardial effusion  1  1/53 (1.89%)  1
cardiac tamponade  1  1/53 (1.89%)  1
chest pain  1  1/53 (1.89%)  1
Infections and infestations   
fever  1  3/53 (5.66%)  3
pneumonia  1  3/53 (5.66%)  3
sepsis  1  1/53 (1.89%)  1
Musculoskeletal and connective tissue disorders   
back pain  1  1/53 (1.89%)  1
myositis  1  1/53 (1.89%)  1
Nervous system disorders   
confusion  1  1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders   
shortness of breath  1  3/53 (5.66%)  3
hypoxia  1  1/53 (1.89%)  1
pneumonitis  1  2/53 (3.77%)  2
hemoptysis  1  1/53 (1.89%)  1
Skin and subcutaneous tissue disorders   
cellulitis  1  2/53 (3.77%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Chemotherapy
Affected / at Risk (%) # Events
Total   36/53 (67.92%)    
Blood and lymphatic system disorders   
Grade 4 hematologic  1  14/53 (26.42%)  24
Grade 3 hematologic  1  22/53 (41.51%)  58
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Since this design did not specify a rule for declaring the treatment as “active” a direct comparison to a standard 2 stage phase 2 design is not appropriate.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: SARC Chief Operating Officer
Organization: SARC
Phone: 734-930-7600
EMail: sarc@sarctrials.org
Publications:
Kilgour-Christie J, Czarnecki A: Pulmonary adverse drug reactions in patients treated with gemcitabine and a combination of gemcitabine and a taxane. [Abstract] J Clin Oncol 23 (Suppl 16): A-8274, 796s, 2005.
Layout table for additonal information
Responsible Party: Shreyaskumar Patel, MD, SARC
ClinicalTrials.gov Identifier: NCT00073983     History of Changes
Obsolete Identifiers: NCT00070772
Other Study ID Numbers: SARC003
First Submitted: December 10, 2003
First Posted: December 11, 2003
Results First Submitted: March 15, 2011
Results First Posted: March 12, 2012
Last Update Posted: March 12, 2012