Expired Study
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New York, New York 10032


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.

Study summary:

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. 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.


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 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) 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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

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

Official Title:

Phase II Evaluation of Irinotecan (CPT-11) in Previously Treated Advanced Sarcomas

Overall Status:

Active, not recruiting

Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Robert N. Taub, MD, PhD
Study Chair
Herbert Irving Comprehensive Cancer Center

Study Dates

Start Date:July 1997
Verification Date:August 2001
Last Changed Date:January 3, 2014
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:irinotecan hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Herbert Irving Comprehensive Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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