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

This study has been completed.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00053833
  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
Peritoneal Cavity Cancer
Drug: irinotecan hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

Drug Information available for:   Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 2003
Primary Completion Date:   October 2005 (Final data collection date for primary outcome measure)

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  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


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

Study ID Numbers:   CDR0000269486, SWOG-S0025
First Received:   February 5, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00053833
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer  
fallopian tube cancer  
peritoneal cavity cancer  
stage III ovarian epithelial cancer  
stage IV ovarian epithelial cancer  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Irinotecan
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Camptothecin
Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Genital Diseases, Female
Endocrinopathy
Fallopian tube cancer
Taxane
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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