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
Condition: Sarcoma
MeSH terms: Sarcoma; Osteosarcoma; Sarcoma, Ewing; Chondrosarcoma; Recurrence
Intervention: filgrastim; pegfilgrastim; docetaxel; gemcitabine hydrochloride; microarray analysis; laboratory biomarker analysis; pharmacokinetic study
Intervention description: filgrastim; pegfilgrastim; docetaxel; gemcitabine hydrochloride; microarray analysis; laboratory biomarker analysis; pharmacokinetic study
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; chondrosarcoma; recurrent osteosarcoma

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.
    

Eligibility 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 (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