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

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00087087
Collaborator
National Cancer Institute (NCI) (NIH), Eli Lilly and Company (Industry)
51
Enrollment
35
Locations
1.5
Patients Per Site

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: pemetrexed disodium
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
51 participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Antitumor activity []

  2. Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 CCOP - Kalamazoo Kalamazoo Michigan United States 49008
6 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
7 CCOP - Kansas City Kansas City Missouri United States 64131
8 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65802
9 St. John's Regional Health Center Springfield Missouri United States 65804
10 Hulston Cancer Center at Cox Medical Center South Springfield Missouri United States 65807
11 Women's Cancer Center - Las Vegas Las Vegas Nevada United States 89102
12 UMDNJ University Hospital Newark New Jersey United States 07103
13 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
14 SUNY Downstate Medical Center Brooklyn New York United States 11203
15 Stony Brook University Cancer Center Stony Brook New York United States 11794-8174
16 Hope A Women's Cancer Center Asheville North Carolina United States 28801
17 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599-7295
18 Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina United States 28232-2861
19 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
20 McDowell Cancer Center at Akron General Medical Center Akron Ohio United States 44307
21 Case Comprehensive Cancer Center Cleveland Ohio United States 44106
22 MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland Ohio United States 44109
23 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
24 CCOP - Dayton Dayton Ohio United States 45429
25 Oklahoma University Medical Center Oklahoma City Oklahoma United States 73104
26 Cancer Care Associates - Midtown Tulsa Tulsa Oklahoma United States 74104
27 Williamette Gynecologic Oncology PC Salem Oregon United States 97301
28 Rosenfeld Cancer Center at Abington Memorial Hospital Abington Pennsylvania United States 19001
29 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania United States 18105
30 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283
31 Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania United States 19111-2497
32 Baptist Regional Cancer Center at Baptist Hospital of East Tennessee Knoxville Tennessee United States 37901
33 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas United States 75390
34 M.D. Anderson Cancer Center at University of Texas Houston Texas United States 77030-4009
35 Massey Cancer Center at Virginia Commonwealth University Richmond Virginia United States 23298-0037

Sponsors and Collaborators

  • Gynecologic Oncology Group
  • National Cancer Institute (NCI)
  • Eli Lilly and Company

Investigators

  • Study Chair: David S. Miller, MD, Simmons Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00087087
Other Study ID Numbers:
  • GOG-0126Q
  • LILLY-H3E-US-JMGP
  • CDR0000372919
First Posted:
Jul 12, 2004
Last Update Posted:
Feb 14, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Gynecologic Oncology Group
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer
Additional relevant MeSH terms:
Pemetrexed

Study Results

No Results Posted as of Feb 14, 2014