Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas

NCT00005874 | Completed Phase 2

• 3 other identifiers: CDR0000067910SUPERGEN-RFS2000-24MDA-DM-99109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Stromal Tumor; Sarcoma; Small Intestine Cancer

Keywords

adult leiomyosarcoma; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; small intestine leiomyosarcoma; metastatic childhood soft tissue sarcoma; recurrent childhood soft tissue sarcoma; childhood leiomyosarcoma; gastrointestinal stromal tumor; stage IV adult soft tissue sarcoma

Interventions

rubitecan DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Astex Pharmaceuticals, Inc.: lead

Study Sites (1)

SuperGen, Incorporated

Dublin, California, 94568, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Sarcoma; Leiomyosarcoma

Interventions

rubitecan

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Muscle Tissue

Study Officials

• Show-Li Sun, MD

  Astex Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: April 13, 2004
• Study Start: June 1, 1999
• Study Completion: April 1, 2004
• Last Updated: December 4, 2013

Record last verified: 2001-09

Locations

US (1)