Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer

NCT00087100 | Completed Phase 2 DMC

• 3 other identifiers: GOG-0129OLILLY-H3E-US-JMGTCDR0000372921
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 23

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 persistent or recurrent endometrial cancer.

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma; endometrial adenocarcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma

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 endometrial adenocarcinoma * Persistent or recurrent disease * Refractory to curative or standard therapy * Measurable disease * At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques, including 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 unless progression is documented or biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy * Must have received 1 prior chemotherapy regimen for endometrial cancer * Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * 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 * AST and ALT ≤ 3 times upper limit of normal (ULN)\* * Alkaline phosphatase ≤ 3 times ULN\* * Bilirubin ≤ 1.5 times ULN NOTE: \* ≤ 5 times ULN if liver metastases are present Renal * Creatinine clearance ≥ 45 mL/min Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study participation * Neuropathy (sensory and motor) ≤ 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 malignant tumor * One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following: * Monoclonal antibodies * Cytokines * Small-molecule inhibitors of signal transduction * At least 24 hours since prior growth factors * No concurrent routine colony-stimulating factors Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No more than 1 prior cytotoxic chemotherapy regimen with either single or combination cytotoxic drug therapy * No prior pemetrexed disodium Endocrine therapy * At least 1 week since prior hormonal therapy directed at the malignant tumor * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * At least 2 weeks since prior radiotherapy and recovered * No prior radiotherapy to ≥ 25% of bone marrow Surgery * Recovered from prior surgery Other * At least 3 weeks since other prior therapy directed at the malignant tumor * No nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days after study drug administration * Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed * No prior therapy that would contraindicate study participation

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

Study Sites (23)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216, 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

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, 27216, United States

Location

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

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

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Midtown Tulsa

Tulsa, Oklahoma, 74104, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

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

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Miller DS, Blessing JA, Drake RD, Higgins R, McMeekin DS, Puneky LV, Krasner CN. A phase II evaluation of pemetrexed (Alimta, LY231514, IND #40061) in the treatment of recurrent or persistent endometrial carcinoma: a phase II study of the Gynecologic Oncology. Gynecol Oncol. 2009 Dec;115(3):443-6. doi: 10.1016/j.ygyno.2009.09.004. Epub 2009 Oct 4.

  PMID: 19804902 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

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: May 1, 2006
• Primary Completion: August 1, 2007
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (23)