A Trial for Patients With Gestational Trophoblastic Disease

This study has been completed.
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190918
First received: September 12, 2005
Last updated: August 7, 2007
Last verified: August 2007

September 12, 2005
August 7, 2007
July 2006
Not Provided
To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Same as current
Complete list of historical versions of study NCT00190918 on ClinicalTrials.gov Archive Site
To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Same as current
Not Provided
Not Provided
 
A Trial for Patients With Gestational Trophoblastic Disease
A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Trophoblastic Neoplasms
  • Uterine Neoplasms
  • Hydatidiform Mole
  • Choriocarcinoma
Drug: Pemetrexed
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2007
Not Provided

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00190918
8366, H3E-US-JMGR
Not Provided
Not Provided
Eli Lilly and Company
Gynecologic Oncology Group
Study Chair: David Miller, MD Gynecologic Oncology Group
Eli Lilly and Company
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP