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

NCT00087087 | Completed Phase 2 DMC

• 3 other identifiers: GOG-0126QLILLY-H3E-US-JMGPCDR0000372919
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 35

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.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (2)

• Antitumor activity

• Toxicity

Interventions

pemetrexed disodium DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (35)

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49008, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Women's Cancer Center - Las Vegas

Las Vegas, Nevada, 89102, United States

Location

UMDNJ University Hospital

Newark, New Jersey, 07103, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-8174, United States

Location

Hope A Women's Cancer Center

Asheville, North Carolina, 28801, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Midtown Tulsa

Tulsa, Oklahoma, 74104, United States

Location

Williamette Gynecologic Oncology PC

Salem, Oregon, 97301, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Baptist Regional Cancer Center at Baptist Hospital of East Tennessee

Knoxville, Tennessee, 37901, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• David S. Miller, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: July 1, 2004
• Primary Completion: December 1, 2006
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (35)