ClinicalTrials.gg
CompletedNCT00087087Updated Feb 14, 2014

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

A Phase 2 interventional study of pemetrexed disodium in Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Gynecologic Oncology Group. Completed at 35 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2014-02-14.

Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Sex
Female
01

Study 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 well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Read the 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 priority treatment protocols.
  • Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

02

Conditions studied

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer

Keywords

  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
03

In context

Ovarian Neoplasms

2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.

This study's planned enrollment of 51 is below the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
51 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Antitumor activity

  2. Toxicity

07

Study locations

35 sites
  • Hinsdale Hematology Oncology Associates
    Hinsdale, Illinois 60521, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • West Michigan Cancer Center
    Kalamazoo, Michigan 49007-3731, United States
  • CCOP - Kalamazoo
    Kalamazoo, Michigan 49008, United States
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
    Columbia, Missouri 65203, United States
  • CCOP - Kansas City
    Kansas City, Missouri 64131, United States
  • CCOP - Cancer Research for the Ozarks
    Springfield, Missouri 65802, United States
  • St. John's Regional Health Center
    Springfield, Missouri 65804, United States
  • Hulston Cancer Center at Cox Medical Center South
    Springfield, Missouri 65807, United States
  • Women's Cancer Center - Las Vegas
    Las Vegas, Nevada 89102, United States
  • UMDNJ University Hospital
    Newark, New Jersey 07103, United States
  • Cancer Institute of New Jersey at Cooper - Voorhees
    Voorhees Township, New Jersey 08043, United States
  • SUNY Downstate Medical Center
    Brooklyn, New York 11203, United States
  • Stony Brook University Cancer Center
    Stony Brook, New York 11794-8174, United States
  • Hope A Women's Cancer Center
    Asheville, North Carolina 28801, United States
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    Chapel Hill, North Carolina 27599-7295, United States
  • Blumenthal Cancer Center at Carolinas Medical Center
    Charlotte, North Carolina 28232-2861, United States
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
  • McDowell Cancer Center at Akron General Medical Center
    Akron, Ohio 44307, United States
  • Case Comprehensive Cancer Center
    Cleveland, Ohio 44106, United States
  • MetroHealth's Cancer Care Center at MetroHealth Medical Center
    Cleveland, Ohio 44109, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • CCOP - Dayton
    Dayton, Ohio 45429, United States
  • Oklahoma University Medical Center
    Oklahoma City, Oklahoma 73104, United States
  • Cancer Care Associates - Midtown Tulsa
    Tulsa, Oklahoma 74104, United States
  • Williamette Gynecologic Oncology PC
    Salem, Oregon 97301, United States
  • Rosenfeld Cancer Center at Abington Memorial Hospital
    Abington, Pennsylvania 19001, United States
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
    Allentown, Pennsylvania 18105, United States
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104-4283, United States
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
  • Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
    Knoxville, Tennessee 37901, United States
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
    Dallas, Texas 75390, United States
  • M.D. Anderson Cancer Center at University of Texas
    Houston, Texas 77030-4009, United States
  • Massey Cancer Center at Virginia Commonwealth University
    Richmond, Virginia 23298-0037, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2004 and a primary completion of Dec 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2004
First posted
Jul 12, 2004
Start
Jul 2004
Primary completionActual
Dec 2006
Last update
Feb 14, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00087087
Responsible party
Sponsor
First posted
Jul 12, 2004
Start date
Jul 2004
Primary completion
Dec 2006
Last update
Feb 14, 2014

Study contacts

David S. Miller, MD
study chair · Simmons Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pemetrexed

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