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

Phase 2
Not Enrolling
Gastrointestinal Stromal Tumor, Sarcoma, Small Intestine Cancer

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Trial Information

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

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

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

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Show-Li Sun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Astex Pharmaceuticals


United States: Federal Government

Study ID:




Start Date:

June 1999

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Sarcoma
  • Small Intestine Cancer
  • 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
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Gastrointestinal Stromal Tumors
  • Intestinal Neoplasms
  • Sarcoma



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