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

This study has been terminated.
(lack of accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00053833
First received: February 5, 2003
Last updated: November 7, 2013
Last verified: November 2013

February 5, 2003
November 7, 2013
April 2003
July 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00053833 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
Drug: irinotecan
Other Name: camptosar
Experimental: irinotecan
irinotecan
Intervention: Drug: irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
July 2004
July 2004   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00053833
CDR0000269486, S0025, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Amy D. Tiersten, MD New York University School of Medicine
Southwest Oncology Group
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP