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A Trial for Patients With Gestational Trophoblastic Disease

Primary Purpose

Trophoblastic Neoplasms, Uterine Neoplasms, Hydatidiform Mole

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trophoblastic Neoplasms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT) WHO score 2-6 (re-evaluated at the time of relapse Histologically confirmed complete or partial moles on initial evacuation Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed. All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration. Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy. Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy. Exclusion Criteria: Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid). Patients with more than 8 metastatic lesions identified Patients with metastases to liver, spleen, brain, kidney or GI tract

Sites / Locations

  • Gynecologic Oncology Group 215-854-0770

Outcomes

Primary Outcome Measures

To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

Secondary Outcome Measures

To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

Full Information

First Posted
September 12, 2005
Last Updated
August 7, 2007
Sponsor
Eli Lilly and Company
Collaborators
Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00190918
Brief Title
A Trial for Patients With Gestational Trophoblastic Disease
Official Title
A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company
Collaborators
Gynecologic Oncology Group

4. Oversight

5. Study Description

Brief Summary
This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trophoblastic Neoplasms, Uterine Neoplasms, Hydatidiform Mole, Choriocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Primary Outcome Measure Information:
Title
To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Secondary Outcome Measure Information:
Title
To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT) WHO score 2-6 (re-evaluated at the time of relapse Histologically confirmed complete or partial moles on initial evacuation Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed. All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration. Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy. Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy. Exclusion Criteria: Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid). Patients with more than 8 metastatic lesions identified Patients with metastases to liver, spleen, brain, kidney or GI tract
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Miller, MD
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
Gynecologic Oncology Group 215-854-0770
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Trial for Patients With Gestational Trophoblastic Disease

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