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Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma - Article


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Soft Tissue Sarcoma

Rhabdomyosarcoma; Sarcoma, Soft Tissue


Clinical Trial: Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma

This study is no longer recruiting patients.

Sponsored by: Herbert Irving Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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 irinotecan in treating patients who have stage IV or recurrent soft tissue sarcoma that has been previously treated with chemotherapy.

Condition Treatment or Intervention Phase
stage IVB adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage IVA adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
 Drug: irinotecan
Phase II

MedlinePlus related topics:  Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Irinotecan in Patients with Stage IV or Recurrent Soft Tissue Sarcoma

Further Study Details: 

Study start: July 1997

OBJECTIVES: I. Evaluate the efficacy of irinotecan in patients with metastatic, recurrent, or unresectable locally advanced previously treated soft tissue sarcoma. II. Assess the clinical and laboratory toxic effects and patient tolerance of this regimen in these patients.

PROTOCOL OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks, followed by 2 weeks of rest. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for the first two years, then every 6 months for the next two years, and every 12 months thereafter until death.

PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study in 18-36 months.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: Prior biologic response modifier therapy allowed
  • Chemotherapy: See Disease Characteristics; No prior irinotecan or topotecan; No other concurrent chemotherapy
  • Endocrine therapy: No concurrent hormonal therapy
  • Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy and recovered; No concurrent radiotherapy
  • Surgery: At least 4 weeks since prior surgery and recovered

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: SWOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: Platelet count at least lower limit of normal; WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,750/mm3
  • Hepatic: Bilirubin no greater than 1.5 mg/dL; AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN with liver tumor involvement)
  • Renal: Creatinine less than ULN OR Creatinine clearance greater than 60 mL/min; Calcium less than ULN
  • Cardiovascular: No myocardial infarction within past 6 months; No congestive heart failure requiring therapy
  • Other: Not pregnant or nursing; Fertile patients must use effective contraception; No physical, mental, or emotional disorders; No other prior malignancy within the past 5 years, except: Adequately treated basal or squamous cell skin cancer; Carcinoma in situ of the cervix; Adequately treated stage I or II cancer in complete remission; No active or uncontrolled infection; HIV negative; No known Gilbert's syndrome; No uncontrolled diabetes (random blood sugar at least 200 mg)

Location Information


New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

Study chairs or principal investigators

Robert N. Taub,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066828; CPMC-IRB-8100; NCI-V98-1511
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003719
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 8, 2008



Page Updated: October 3, 2005
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