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Status:

COMPLETED

Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Eli Lilly and Company

Conditions:

Ovarian Cancer

Primary Peritoneal Cavity Cancer

Eligibility:

FEMALE

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how ...

Detailed Description

OBJECTIVES: * Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher pr...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed ovarian epithelial or primary peritoneal cancer
  • Recurrent or persistent disease
  • Measurable disease
  • At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
  • Tumors within a previously irradiated field are considered non-target lesions
  • Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease
  • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel
  • Platinum-resistant or refractory disease
  • Treatment-free interval \< 6 months after prior platinum-based therapy OR progressed during platinum-based therapy
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
  • PATIENT CHARACTERISTICS:
  • Age
  • Any age
  • Performance status
  • GOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN\*
  • AST and ALT ≤ 3 times ULN\* NOTE: \* ≤ 5 times ULN if due to hepatic metastases
  • Renal
  • Creatinine clearance ≥ 45 mL/min
  • Other
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No neuropathy (sensory or motor) \> grade 1
  • No active infection requiring antibiotics
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study treatment
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following:
  • Monoclonal antibodies
  • Cytokines
  • Small-molecule inhibitors of signal transduction
  • At least 3 weeks since prior biologic or immunologic therapy
  • At least 24 hours since prior growth factors
  • No concurrent routine colony-stimulating factors
  • Chemotherapy
  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
  • No prior pemetrexed disodium
  • Endocrine therapy
  • At least 1 week since prior hormonal therapy for the malignant tumor
  • Concurrent hormone replacement therapy allowed
  • Radiotherapy
  • See Disease Characteristics
  • No prior radiotherapy to \> 25% of bone marrow
  • At least 2 weeks since prior radiotherapy and recovered
  • Surgery
  • Recovered from prior surgery
  • Other
  • No prior cancer treatment that would preclude study participation
  • No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration
  • Concurrent low-dose (≤ 325 mg/day) aspirin allowed
  • At least 3 weeks since other prior therapy for the malignant tumor

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    51 Patients enrolled

    Trial Details

    Trial ID

    NCT00087087

    Start Date

    July 1 2004

    Last Update

    February 14 2014

    Active Locations (35)

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

    Page 1 of 9 (35 locations)

    1

    Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, United States, 60521

    2

    CCOP - Carle Cancer Center

    Urbana, Illinois, United States, 61801

    3

    Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, United States, 02114

    4

    West Michigan Cancer Center

    Kalamazoo, Michigan, United States, 49007-3731