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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
This study is ongoing, but not recruiting participants.

First Received on December 10, 2003.   Last Updated on March 10, 2011   History of Changes
Sponsor: Sarcoma Alliance for Research through Collaboration
Collaborator: National Cancer Institute (NCI)
Information provided by: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00073983
  Purpose

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 (closed to accrual as of 12/21/06), recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.


Condition Intervention Phase
Sarcoma
 Biological: filgrastim
Biological: pegfilgrastim
Drug: docetaxel
Drug: gemcitabine hydrochloride
Genetic: microarray analysis
Other: laboratory biomarker analysis
Other: pharmacological study
 Phase II

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study]

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Gemcitabine Docetaxel Filgrastim Gemcitabine hydrochloride Lenograstim Granulocyte colony-stimulating factor Pegfilgrastim
U.S. FDA Resources

Further study details as provided by Sarcoma Alliance for Research through Collaboration:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Various time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Various time points ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: Per protocol ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: October 2006
Estimated Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: filgrastim
    filgrastim
    Biological: pegfilgrastim
    pegfilgrastim
    Drug: docetaxel
    docetaxel
    Drug: gemcitabine hydrochloride
    gemcitabine hydrochloride
    Genetic: microarray analysis
    microarray analysis
    Other: laboratory biomarker analysis
    laboratory biomarker analysis
    Other: pharmacological study
    pharmacological study
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with recurrent osteosarcoma (closed to accrual as of 12/21/06) or Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel.

Secondary

  • 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 [closed to accrual as of 12/21/06] vs recurrent Ewing's sarcoma vs unresectable or locally recurrent chondrosarcoma).

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV 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.

Blood samples are collected at baseline and periodically during study for pharmacokinetics studies. 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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 4 and over

Performance status

  • ECOG 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

Hematopoietic

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

Hepatic

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

Renal

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

  • No concurrent surgery

Other

  • Recovered from all prior therapy
  • No other concurrent investigational anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073983

Sponsors and Collaborators
Sarcoma Alliance for Research through Collaboration
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shreyaskumar R. Patel, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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.

Responsible Party: Shreyaskumar Patel, MD, MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00073983     History of Changes
Obsolete Identifiers: NCT00070772
Other Study ID Numbers: SARC003, U10CA013539, SARC003, NCI-04-C-0001, MAYO-79-2003
Study First Received: December 10, 2003
Last Updated: March 10, 2011
Health Authority: United States: Federal Government

Keywords provided by Sarcoma Alliance for Research through Collaboration:
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
chondrosarcoma
recurrent osteosarcoma

Additional relevant MeSH terms:
Chondrosarcoma
Osteosarcoma
Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Gemcitabine
Docetaxel
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012



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