Brief Title
S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
S0025: Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube 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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
irinotecan
Study Arms / Comparison Groups
irinotecan
Description: irinotecan
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
2
Start Date
April 2003
Completion Date
July 2004
Primary Completion Date
July 2004
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Amy D. Tiersten, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00053833
Organization ID
CDR0000269486
Secondary IDs
S0025
Responsible Party
Sponsor
Study Sponsor
Southwest Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Amy D. Tiersten, MD, Study Chair, NYU Langone Health
Verification Date
November 2013