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

This study has been terminated.
(lack of accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00053833
First received: February 5, 2003
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
 Drug: irinotecan
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S0025: Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Enrollment: 2
Study Start Date: April 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: irinotecan
irinotecan
 Drug: irinotecan
Other Name: camptosar

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053833

  Show 100 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Amy D. Tiersten, MD New York University School of Medicine
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00053833     History of Changes
Other Study ID Numbers: CDR0000269486, S0025, U10CA032102
Study First Received: February 5, 2003
Last Updated: November 15, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
 Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013