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.
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
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--
- Histologically or cytologically confirmed recurrent or stage IV (metastatic or locally advanced) unresectable soft tissue sarcoma; Patients with soft tissue; Ewing's sarcoma, Kaposi's sarcoma, sarcoma of the bone, and mesothelioma are not eligible; Must have failed at least one, but no more than two, prior chemotherapy regimens, one of which contained doxorubicin either as adjuvant therapy or first-line therapy for metastatic disease
- Bidimensionally measurable disease on x-ray, MRI or CT scan, or physical exam (outside of previously irradiated area)
- No CNS metastases
--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
Robert N. Taub, Study Chair, Herbert Irving Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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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