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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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

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

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.

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert N. Taub, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

Related Keywords:

  • Sarcoma
  • stage IV adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • Sarcoma



Herbert Irving Comprehensive Cancer Center New York, New York  10032