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Status:

COMPLETED

Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Fallopian Tube Cancer

Ovarian Cancer

Eligibility:

FEMALE

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in d...

Detailed Description

OBJECTIVES: Primary * Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
  • Recurrent disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • At least 1 target lesion not in a previously irradiated field
  • Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound
  • Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Patients who have not received prior paclitaxel may receive a second regimen that includes paclitaxel
  • Platinum-sensitive disease
  • Treatment-free interval\* without clinical evidence of progressive disease for \> 6 months after prior response to a platinum-based regimen NOTE: \*Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • GOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance \> 40 mL/min
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No sensory or motor neuropathy \> grade 1
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • At least 3 weeks since prior biologic or immunologic agents for the malignancy
  • No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease
  • No concurrent cytokines during the first course of study treatment
  • No concurrent pegfilgrastim
  • Chemotherapy
  • See Disease Characteristics
  • See Biologic therapy
  • Recovered from prior chemotherapy
  • No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen
  • No prior topotecan
  • Endocrine therapy
  • At least 1 week since prior hormonal therapy for the malignancy
  • Concurrent hormone replacement therapy allowed
  • Radiotherapy
  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to \> 25% of marrow-bearing areas
  • Surgery
  • Recovered from prior surgery
  • Other
  • At least 3 weeks since other prior therapy for the malignancy
  • No prior anticancer therapy that would preclude study treatment

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    81 Patients enrolled

    Trial Details

    Trial ID

    NCT00114166

    Start Date

    January 1 2005

    Last Update

    July 24 2018

    Active Locations (78)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 20 (78 locations)

    1

    Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, United States, 06105

    2

    George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, United States, 06050

    3

    Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, United States, 19958

    4

    CCOP - Christiana Care Health Services

    Newark, Delaware, United States, 19713

    Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer | DecenTrialz