A Trial for Patients With Gestational Trophoblastic Disease

Uterine Neoplasms Clinical Trial

Official title:

A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190918
• Other study ID #: 8366
• Secondary ID: H3E-US-JMGR
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: August 7, 2007
• Start date: July 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choriocarcinoma
• Gestational Trophoblastic Disease
• Hydatidiform Mole
• Neoplasms
• Trophoblastic Neoplasms
• Uterine Neoplasms

Intervention

Drug:
• Pemetrexed

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group 215-854-0770	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Secondary	To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

External Links

•   Lilly Clinical Trial Registry