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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00096187

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

2.2

Patients Per Site

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2005

Actual Primary Completion Date :

Jul 23, 2007

Outcome Measures

Primary Outcome Measures

Activity []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

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