A Trial for Patients With Gestational Trophoblastic Disease
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ClinicalTrials.gov Identifier: NCT00190918 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : August 9, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Trophoblastic Neoplasms Uterine Neoplasms Hydatidiform Mole Choriocarcinoma | Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
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 |
Study Start Date : | July 2006 |
Actual Study Completion Date : | July 2007 |

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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
United States, Pennsylvania | |
Gynecologic Oncology Group 215-854-0770 | |
Philadelphia, Pennsylvania, United States |
Study Chair: | David Miller, MD | Gynecologic Oncology Group |
ClinicalTrials.gov Identifier: | NCT00190918 |
Other Study ID Numbers: |
8366 H3E-US-JMGR |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | August 9, 2007 |
Last Verified: | August 2007 |
Neoplasms Choriocarcinoma Uterine Neoplasms Hydatidiform Mole 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 Gestational Trophoblastic Disease Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |