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A Trial for Patients With Gestational Trophoblastic Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190918
First Posted: September 19, 2005
Last Update Posted: August 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company
  Purpose
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.

Condition Intervention Phase
Trophoblastic Neoplasms Uterine Neoplasms Hydatidiform Mole Choriocarcinoma Drug: Pemetrexed Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Estimated Enrollment: 50
Study Start Date: July 2006
Study Completion Date: July 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190918


Locations
United States, Pennsylvania
Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Eli Lilly and Company
Gynecologic Oncology Group
Investigators
Study Chair: David Miller, MD Gynecologic Oncology Group
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00190918     History of Changes
Other Study ID Numbers: 8366
H3E-US-JMGR
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: August 9, 2007
Last Verified: August 2007

Additional relevant MeSH terms:
Neoplasms
Choriocarcinoma
Uterine Neoplasms
Hydatidiform Mole
Gestational Trophoblastic Disease
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors