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

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

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