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

Phase 2
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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)

- 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



- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No myocardial infarction within the past 6 months

- No angina pectoris

- No uncontrolled congestive heart failure

- No uncontrolled cardiac arrhythmia


- 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


Biologic therapy

- No more than 1 prior biological response modifier

- At least 28 days since prior biological response modifier and recovered


- 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

Endocrine therapy

- Prior hormonal therapy allowed

- No concurrent hormonal therapy


- At least 28 days since prior radiotherapy and recovered

- No prior radiotherapy to more than 25% of bone marrow

- No concurrent palliative radiotherapy


- At least 14 days since prior major surgery and recovered


- At least 28 days since prior investigational drugs and recovered

- No other concurrent antitumor therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Amy D. Tiersten, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

July 2004

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



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