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

Primary Purpose

Gestational Trophoblastic Tumor

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pemetrexed disodium
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Trophoblastic Tumor focused on measuring low risk metastatic gestational trophoblastic tumor, recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
  • Providence Saint Joseph Medical Center - Burbank
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Hinsdale Hematology Oncology Associates
  • CCOP - Carle Cancer Center
  • Holden Comprehensive Cancer Center at University of Iowa
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Duke Comprehensive Cancer Center
  • Wilson Medical Center
  • Charles M. Barrett Cancer Center at University Hospital
  • Case Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • Riverside Methodist Hospital Cancer Care
  • Hillcrest Cancer Center at Hillcrest Hospital
  • Lake/University Ireland Cancer Center
  • Oklahoma University Cancer Institute
  • Rosenfeld Cancer Center at Abington Memorial Hospital
  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • UMC Southwest Cancer and Research Center

Outcomes

Primary Outcome Measures

Activity
Toxicity

Secondary Outcome Measures

Full Information

First Posted
November 9, 2004
Last Updated
April 11, 2018
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00096187
Brief Title
Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy
Official Title
A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 23, 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Trophoblastic Tumor
Keywords
low risk metastatic gestational trophoblastic tumor, recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pemetrexed disodium
Primary Outcome Measure Information:
Title
Activity
Title
Toxicity

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Miller, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Allan Covens, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Providence Saint Joseph Medical Center - Burbank
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wilson Medical Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893-3428
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
Hillcrest Cancer Center at Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Lake/University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Rosenfeld Cancer Center at Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UMC Southwest Cancer and Research Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415-3364
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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