S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

SWOG Cancer Research Network

Status and phase: Terminated; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: irinotecan

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00053833

CDR0000269486

S0025 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Full description

OBJECTIVES:

• Determine the objective confirmed and unconfirmed complete and partial response rates of patients with platinum- and taxane-refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with irinotecan.
• Determine the progression-free and overall survival of patients treated with this drug.
• Evaluate the qualitative and quantitative toxic effects of this drug in these patients.

OUTLINE: Patients receive irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Enrollment: 2 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or pathologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer

  • No mixed mullerian and borderline ovarian tumors

• Surgically staged as stage III or IV at initial diagnosis

• Must meet one of the following criteria for refractory/relapsed disease:

  • Relapsed within 6 months after completing front-line concurrent or sequential platinum (either cisplatin or carboplatin) and taxane (paclitaxel or docetaxel) chemotherapy

  • Had a best response of increasing disease during this front-line regimen

    • Consolidation chemotherapy and reinduction therapy are counted as part of the front-line regimen

• Unidimensionally measurable disease

  • At least 2 cm by medical photograph (skin or oral lesion), palpation, plain x-ray, CT scan, MRI, or other conventional technique (bone lesions not included)
  • At least 1 cm by spiral CT scan
  • Measurable disease must remain outside of radiotherapy field

• If the tumor is known to be KIT (CD117) or PDGFR positive, patient must be offered SWOG-S0211 if available

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No myocardial infarction within the past 6 months
• No angina pectoris
• No uncontrolled congestive heart failure
• No uncontrolled cardiac arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except for the following:

  • Adequately treated basal cell or squamous cell skin cancer
  • Carcinoma in situ of the cervix
  • Adequately treated stage I or II cancer from which the patient is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No more than 1 prior biological response modifier
• At least 28 days since prior biological response modifier and recovered

Chemotherapy

• See Disease Characteristics
• No prior topotecan or other topoisomerase I inhibitor
• One other additional prior chemotherapy regimen allowed
• At least 28 days since prior chemotherapy (14 days for weekly chemotherapy) and recovered

Endocrine therapy

• Prior hormonal therapy allowed
• No concurrent hormonal therapy

Radiotherapy

• At least 28 days since prior radiotherapy and recovered
• No prior radiotherapy to more than 25% of bone marrow
• No concurrent palliative radiotherapy

Surgery

• At least 14 days since prior major surgery and recovered

Other

• At least 28 days since prior investigational drugs and recovered
• No other concurrent antitumor therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

irinotecan

Experimental group

Description:

irinotecan

Treatment:

Drug: irinotecan