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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. Identifier: NCT00073983
Recruitment Status : Completed
First Posted : December 11, 2003
Results First Posted : March 12, 2012
Last Update Posted : March 12, 2012
Information provided by:
Sarcoma Alliance for Research through Collaboration

Tracking Information
First Submitted Date  ICMJE December 10, 2003
First Posted Date  ICMJE December 11, 2003
Results First Submitted Date  ICMJE March 15, 2011
Results First Posted Date  ICMJE March 12, 2012
Last Update Posted Date March 12, 2012
Study Start Date  ICMJE October 2006
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
Objective Response Rate [ Time Frame: After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00073983 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
  • Time to Progression [ Time Frame: post-cycle 2, 4, 8 and 12 ]
    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.
  • Toxicity as Assessed by NCI CTCAE v3.0 [ Time Frame: Throughout the study ]
    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.
  • Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study [ 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. ]
    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.
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 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
Official Title  ICMJE Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study]
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.

Detailed Description



  • Determine the objective response rate in patients with recurrent osteosarcoma or Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel.


  • Determine the time to progression in patients treated with this regimen.
  • Assess the toxicity of this regimen in these patients.
  • Compare the pharmacokinetics of this regimen vs gemcitabine alone in these patients.
  • Obtain tumor samples for cDNA microarray analysis of gene expression and development of cell lines and xenotransplantation models.

OUTLINE: This is a nonrandomized, multicenter study.

Patients are stratified according to diagnosis recurrent osteosarcoma vs recurrent Ewing's sarcoma vs unresectable or locally recurrent chondrosarcoma).

Patients receive gemcitabine intravenously over 90 minutes on days 1 and 8 and docetaxel intravenously over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover. Patients may receive pegfilgrastim SC on day 9 (once per course) as an alternative to G-CSF. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Optional blood samples are collected at baseline and periodically during study for pharmacokinetics studies. Optional tumor tissue samples from biopsy or surgical resection are analysed for cDNA microarray analysis of gene expression.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A maximum of 120 patients (40 per stratum) will be accrued for this study within 17-24 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE
  • Biological: filgrastim
  • Biological: pegfilgrastim
  • Drug: docetaxel
  • Drug: gemcitabine hydrochloride
    gemcitabine hydrochloride
  • Genetic: microarray analysis
    microarray analysis
  • Other: laboratory biomarker analysis
    laboratory biomarker analysis
  • Other: pharmacokinetic study
    pharmacokinetic study
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2011)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • Histologically confirmed* diagnosis of 1 of the following:

    • Recurrent high-grade osteosarcoma (closed to accrual as of 12/21/06) or Ewing's sarcoma

      • Progressive disease after standard therapy
      • Received no more than 2 additional salvage regimens
    • Chondrosarcoma

      • Unresectable OR locally recurrent and unable to be completely resected NOTE: *Biopsy required for isolated pulmonary recurrences
  • Measurable disease

    • At least 1 unidimensionally measurable lesion by medical imaging techniques
    • Ascites, pleural effusions, and bone marrow disease are not considered measurable disease



  • 4 and over

Performance status

  • ECOG (Eastern Cooperative Oncology Group) 0-2 (≥ 18 years of age)
  • Karnofsky 50-100% (11-17 years of age)
  • Lansky 50-100% (≤ 10 years of age)

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)


  • Bilirubin ≤ upper limit of normal (ULN) (except for patients with Gilbert's syndrome)
  • ALT ≤ 2.5 times ULN


  • Creatinine clearance or radioisotope glomerular filtration rate > 70 mL/min/1.73 m^2 OR
  • Serum creatinine ≤ ULN for age:

    • Ages 5 and under ≤ 0.8 mg/dL
    • Ages 6 to 10 ≤ 1.0 mg/dL
    • Ages 11 to 15 ≤ 1.2 mg/dL
    • Ages 16 to 18 ≤ 1.5 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • Sensory or motor neuropathy due to prior chemotherapy ≤ grade 1
  • Sensory or motor neuropathy due to prior surgery or tumor involvement ≤ grade 2 AND stable or improving
  • No active or uncontrolled infection
  • No known hypersensitivity reaction to docetaxel or other polysorbate 80-formulated agents


Biologic therapy

  • At least 72 hours since prior filgrastim (G-CSF)
  • No prior allogeneic transplantation
  • No concurrent immunotherapy


  • At least 2 weeks since prior myelosuppressive therapy
  • At least 6 months since prior myeloablative therapy
  • No prior gemcitabine
  • No prior taxanes
  • No other concurrent chemotherapy

Endocrine therapy

  • Concurrent hormonal therapy allowed


  • At least 6 weeks since prior local radiotherapy
  • At least 4 months since prior extensive radiotherapy to more than 50% of the pelvis
  • At least 4 months since prior cranial spinal radiotherapy
  • At least 6 months since prior total body irradiation
  • No concurrent radiotherapy


  • No concurrent surgery


  • Recovered from all prior therapy
  • No other concurrent investigational anticancer therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, 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 Not Provided
Removed Location Countries United States
Administrative Information
NCT Number  ICMJE NCT00073983
Other Study ID Numbers  ICMJE SARC003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shreyaskumar Patel, MD, SARC
Study Sponsor  ICMJE Sarcoma Alliance for Research through Collaboration
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shreyaskumar R. Patel, MD Sarcoma Alliance for Research through Collaboration
Principal Investigator: Elizabeth Fox, MD Sarcoma Alliance for Research through Collaboration
PRS Account Sarcoma Alliance for Research through Collaboration
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP