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Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma



Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

For Condition: recurrent osteosarcoma,Chondrosarcoma,recurrent tumors of the Ewing's family
Status: Not yet recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use 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 recurrentosteosarcoma, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.
Details: OBJECTIVES: Primary - 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. Secondary - Determine the time to progression in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Compare the pharmacokinetics of this regimen vs gemcitabine alone in these patients. 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 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 for up to 14 courses in the absence of disease progression or unacceptable toxicity. 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 10 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed* diagnosis of 1 of the following: - Recurrent high-grade osteosarcoma 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 - 10 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (transfusion allowed) Hepatic - Bilirubin no greater than upper limit of normal (ULN) (except for patients with Gilbert’s syndrome) - ALT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN (for patients with Ewing’s sarcoma or chondrosarcoma and no evidence of bone involvement) - Alkaline phosphatase no greater than ULN OR heat-stable alkaline phosphatase or 5’-nucleotidase no greater than ULN (for patients with osteosarcoma or bone involvement of Ewing’s sarcoma or chondrosarcoma) Renal - Creatinine clearance or radioisotope glomerular filtration rate greater than 70 mL/min OR - Creatinine normal 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 no greater than grade 1 - Sensory or motor neuropathy due to prior surgery or tumor involvement no greater than 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LeeHelman,  Principal Investigator,  Pediatric Oncology Branch


Additional Information:
Study ID Numbers:  CDR0000341555;  NCI-04-C-0001
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073983

Other Chondrosarcoma Studies:
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2. Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

3. Gemcitabine and Docetaxel to Treat Bone and Soft Tissue Cancers

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