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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Gestational Trophoblastic Tumor	Drug: pemetrexed disodium	Phase 2

Detailed Description:

OBJECTIVES:

• Determine the activity of pemetrexed disodium as salvage therapy in patients with persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed prior dactinomycin or methotrexate.
• Determine the 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 unacceptable toxicity or disease progression or until tumor marker levels (human chorionic gonadotropin [hCG]) become normal. Patients receive 2 additional courses beyond the attainment of a normal hCG.

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 2 weeks for 2 months and then monthly for 10 months.

PROJECTED ACCRUAL: Approximately 17-55 patients will be accrued for this study within 20-50 months.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	55 participants
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
Study Start Date :	July 2005
Actual Primary Completion Date :	July 23, 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Activity
2. Toxicity

Eligibility Criteria

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Ages Eligible for Study:	up to 120 Years (Child, Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, Missouri
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
UMC Southwest Cancer and Research Center
Lubbock, Texas, United States, 79415-3364

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	David S. Miller, MD	Simmons Cancer Center
OverallOfficial:	Allan Covens, MD	Toronto Sunnybrook Regional Cancer Centre

More Information

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ClinicalTrials.gov Identifier:	NCT00096187 History of Changes
Other Study ID Numbers:	CDR0000390347; GOG-0217; GOG-UC0205; LILLY-H3E-US-JMGR
First Posted:	November 9, 2004
Last Update Posted:	April 12, 2018
Last Verified:	April 2018

Keywords provided by Gynecologic Oncology Group:

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

Additional relevant MeSH terms:

Trophoblastic Neoplasms; Gestational Trophoblastic Disease; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications	Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors