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

Gestational Trophoblastic Tumor Clinical Trial

Official title:

A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00096187
• Other study ID #: CDR0000390347
• Secondary ID: GOG-0217GOG-UC02
• Status: Terminated
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: April 11, 2018
• Start date: July 2005

Study information

• Verified date: April 2018
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. primary completion date: July 23, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Trophoblastic Neoplasms

Intervention

Drug:
• pemetrexed disodium

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham	Birmingham	Alabama
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	UMC Southwest Cancer and Research Center	Lubbock	Texas
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	Lake/University Ireland Cancer Center	Mentor	Ohio
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Wilson Medical Center	Wilson	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity
Primary	Toxicity