Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy

NCT00096187 | Terminated Phase 2

• 4 other identifiers: CDR0000390347GOG-0217GOG-UC0205LILLY-H3E-US-JMGR
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 25

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 low-risk gestational trophoblastic tumor after a molar pregnancy.

Conditions

Gestational Trophoblastic Tumor

Keywords

low risk metastatic gestational trophoblastic tumor; recurrent gestational trophoblastic tumor; nonmetastatic gestational trophoblastic tumor

Outcome Measures

Primary Outcomes (2)

• Activity

• Toxicity

Interventions

pemetrexed disodium DRUG

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of low-risk post-molar gestational trophoblastic tumor, defined as 1 of the following: * Increasing human chorionic gonadotropin (hCG) levels on ≥ 3 consecutive measurements taken over ≥ a 2-week period * Less than 10% decrease of hCG levels on 4 measurements taken over ≥ a 3-week period * Persistent or recurrent disease * Histologically confirmed complete or partial mole on initial evacuation * Prior pregnancy ≤ 12 months ago * No histologically confirmed choriocarcinoma or placental site trophoblastic tumor on initial evacuation * Failed only 1 prior dactinomycin or methotrexate therapy (with or without leucovorin calcium) * WHO score 2-6 * No evidence of metastatic disease, except to the lung or vagina, on physical exam, chemistry, chest X-ray, and ultrasound * No liver, spleen, brain, kidney, or gastrointestinal tract metastases * No more than 8 metastatic lesions PATIENT CHARACTERISTICS: Age * Any age Performance status * GOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Granulocyte count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 3 times ULN * Alkaline phosphatase ≤ 3 times ULN Renal * Creatinine ≤ 1.5 mg/dL * Creatinine clearance ≥ 45 mL/min Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study participation * No significant infection * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic filgrastim (G-CSF) unless for recurrent neutropenic complications * No concurrent prophylactic thrombopoietic agents unless for recurrent grade 4 thrombocytopenia Chemotherapy * See Disease Characteristics * At least 7 days since prior dactinomycin or methotrexate (with or without leucovorin calcium) and recovered * No prior pemetrexed disodium * No other prior chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 14 days since prior radiotherapy and recovered * No prior radiotherapy to ≥ 25% of the bone marrow Surgery * Recovered from prior surgery Other * No nonsteroidal anti-inflammatory drugs or salicylates for 2 days (or 5 days for drugs with a long half-life) before, during, and for 2 days after pemetrexed disodium administration * Concurrent low-dose aspirin (≤ 325 mg/day) allowed

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 (25)

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242, 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

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, 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

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

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

Dallas, Texas, 75390, United States

Location

UMC Southwest Cancer and Research Center

Lubbock, Texas, 79415-3364, United States

Location

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital 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

• Allan Covens, MD

  Toronto Sunnybrook Regional Cancer Centre

Study Design

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

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: July 1, 2005
• Primary Completion: July 23, 2007
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (25)