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Investigator(s):
Elizabeth Fox, M.D. Phone: 301-402-6641 foxb@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• 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: Accrual to the osteosarcoma cohort has been closed. Accrual to the Ewing’s sarcoma and chondrosarcoma cohorts continues.



• At least 1 unidimensionally measurable lesion by medical imaging techniques (Ascites, pleural effusions, and bone marrow disease are not considered measurable disease)
• Age 4 and over
• No prior gemcitabine or taxanes
• No prior allogeneic transplants
• No history of hypersensitivity reaction to docetaxel or other agents formulated in polysorbate 80
• No active or uncontrolled infections
• No concurrent therapies except hormonal therapy
• Recovery of toxic effects of all prior therapy
• ECOG performance status ≤ 2 for patients ≥ 18 years, Karnofsky score ≥ 50% for patients 11-17 years, Lansky score ≥ 50 for patients ≤ 10 years
• At least 6 weeks since prior local radiotherapy
• At least 4 months since prior extensive radiotherapy to more than 50% of the pelvis or prior cranial spinal radiotherapy
• At least 6 months since prior total body irradiation or myeloablative therapy
• At least 2 weeks since last dose of myelosuppressive therapy
• Adequate organ function defined as:
• Bone marrow: ANC ≥ 1500/mm³, transfusion-independent platelet count ≥ 100,000 mm³, and hemoglobin > 8.0 g/dl (transfusions permitted)
• Renal function: serum normal age adjusted serum creatinine or creatinine clearance or radioisotope GFR > 70 ml/min.1.73 m². Creatinine ≤ ULN for patients ≥ 18 years
• Liver function: bilirubin within normal limits, SGPT (ALT) ≤ 2.5x the ULN. For patients with Gilbert syndrome, total bilirubin > ULN with exemption
• Neuropathy (sensory and motor) due to prior chemotherapy must be ≤ grade 1
• Neuropathy (sensory and motor) due to prior surgery must be ≤ grade 2 and stable or improving
• No pregnant or breast feeding females, and all patients must be willing to use acceptable form of birth control

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Treatment Plan:

This is a nonrandomized, multicenter study

• Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8
• Patients 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
• Patients are followed every 3 months for 1 year and then every 6 months for 1 year

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/12/08
Updated: 10/14/08