Status:
COMPLETED
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
Lead Sponsor:
Sarcoma Alliance for Research through Collaboration
Conditions:
Sarcoma
Eligibility:
All Genders
4+ years
Phase:
PHASE2
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...
Detailed Description
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 gem...
Eligibility Criteria
Inclusion
- 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 (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
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00073983
Start Date
October 1 2006
End Date
December 1 2010
Last Update
March 12 2012
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