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

S0025: Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube Cancer

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00053833
Enrollment
2
Registered
2003-02-06
Start date
2003-04-30
Completion date
2004-07-31
Last updated
2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

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 irinotecan in treating patients who have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Detailed 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.

Interventions

DRUGirinotecan

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion 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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026