Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue Sarcoma

• Status: Completed
• Trial end date: 2008-09-22
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent, locally advanced, or metastatic soft tissue sarcoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Alvocidib

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed previously untreated metastatic or locally advanced soft tissue sarcoma not amenable to standard curative therapies Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Bone lesions are not considered measurable Must have measurable disease outside irradiated area unless evidence of progression or new lesions inside irradiated area No carcinosarcoma, Kaposi's sarcoma, soft tissue Ewing's sarcoma, or embryonal rhabdomyosarcoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Cardiovascular: If history of cardiac disease, cardiac ejection function greater than 50% No clinically significant cardiac symptomatology Pulmonary: If history of symptomatic pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted No clinically significant pulmonary symptomatology Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent serious disease

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation Chemotherapy: No prior chemotherapy for metastatic or locally advanced disease No prior high dose chemotherapy and stem cell transplantation Prior adjuvant chemotherapy allowed At least 6 months since prior chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No more than 25% of functioning bone marrow irradiated No concurrent radiotherapy to sole site of measurable disease Surgery: At least 4 weeks since prior major surgery Other: No other concurrent anticancer therapy