Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	4 and over	NCI	SARC003 NCT00073983, NCI-04-C-0001, AEWS0421, MAYO-79-2003

Special Category: NIH Clinical Center trial

Objectives

Primary

1. 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

1. Determine the time to progression in patients treated with this regimen.
2. Assess the toxicity of this regimen in these patients.
3. Compare the pharmacokinetics of this regimen vs gemcitabine alone in these patients.
4. Obtain tumor samples for cRNA microarray analysis of gene expression and development of cell lines and xenotransplantation models.

Entry 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

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

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/mm³
• Platelet count ≥ 100,000/mm³ (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 m²

  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

Expected Enrollment

A maximum of 120 patients (40 per stratum) will be accrued for this study within 17-24 months.

Outcomes

Objective response rate

Time to progression
Toxicity as assessed by NCI CTCAE v3.0
Pharmacokinetics

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.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

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.

Trial Contact Information

Trial Lead Organizations

Sarcoma Alliance for Research through Collaboration

Kathleen Granlund, Study coordinator		Ph: 734-930-7607

NCI - Center for Cancer Research

Elizabeth Fox, MD, Principal investigator		Ph: 301-402-6641 Email: foxb@mail.nih.gov
Shreyaskumar Patel, MD, Principal investigator		Ph: 713-794-4632; 800-392-1611 Email: spatel@mdanderson.org

U.S.A.
California
	Los Angeles
	Century City Doctor's Hospital
		Sant Chawla, MD	Ph:  310-552-9999
	Santa Monica
	Sarcoma Oncology Center
		Sant Chawla, MD	Ph:  310-552-9999
			Email: santchawla@aol.com
District of Columbia
	Washington
	Washington Cancer Institute at Washington Hospital Center
		Clinical Trials Office - Washington Cancer Institute	Ph:  202-877-8839
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Gina D'Amato, MD	Ph:  404-778-5180 888-946-7447
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		George Demetri, MD	Ph:  617-632-3985 866-790-4500
			Email: gdemetri@partners.org
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Scott Schuetze, MD, PhD	Ph:  734-615-4762
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Christopher Ryan, MD	Ph:  503-494-6594
			Email: ryanc@ohsu.edu
Pennsylvania
	Philadelphia
	Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
		Arthur Staddon, MD	Ph:  215-829-6088 800-789-7366
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245

Registry Information
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]
Trial Start Date		2006-10-04
Trial Completion Date		2009-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00073983
Date Submitted to PDQ		2003-10-17
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA13539

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