Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas

Sarcoma Clinical Trial

Official title:

Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Soft-Tissue Sarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005874
• Other study ID #: CDR0000067910
• Secondary ID: SUPERGEN-RFS2000
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: December 3, 2013
• Start date: June 1999
• Est. completion date: April 2004

Study information

• Verified date: September 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 nitrocamptothecin in treating patients who have locally advanced or metastatic soft tissue sarcomas.

Description:

OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with locally advanced or metastatic gastrointestinal leiomyosarcomas or other soft tissue sarcomas.

OUTLINE: Patients are stratified by disease (gastrointestinal leiomyosarcomas vs other soft tissue sarcomas). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Responding patients who undergo surgery then receive an additional 4-6 courses (4 weeks/course).

PROJECTED ACCRUAL: A total of 34-78 patients (17-39 per stratum) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic inoperable soft tissue sarcoma Measurable or evaluable disease that has not been irradiated Must have received, refused, or be not eligible for doxorubicin/ifosfamide treatment Previously untreated gastrointestinal leiomyosarcoma allowed

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 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 1.5 mg/dL Transaminases no greater than 3 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No active coronary disease requiring therapy Pulmonary: No severe pulmonary insufficiency Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other prior malignancy in past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No concurrent active infections No psychosis or mental disability that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior biological therapy and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: At least 7 days since prior hormonal therapy and recovered Radiotherapy: See Disease Characteristics Surgery: Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Sarcoma
• Small Intestine Cancer

Intervention

Drug:
• rubitecan

Locations

Country	Name	City	State
United States	SuperGen, Incorporated	Dublin	California

Sponsors (1)

Lead Sponsor	Collaborator
Astex Pharmaceuticals

Country where clinical trial is conducted

United States,