Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors

Completed · Phase 2

Conditions studied: Complete Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Partial Hydatidiform Mole

In brief

This phase II trial studies how well a second curettage (removal of the abnormal cancer cells in the uterus using a method of surgically removing the lining of the uterus) works in treating patients with gestational trophoblastic tumors that did not go away after a first curettage (persistent) and has not yet spread to other places in the body (non-metastatic). A second curettage may be effective in treating persistent gestational trophoblastic tumors and may decrease the likelihood that patients will need chemotherapy in the near future.

Key facts

Study ID: NCT00521118
Run by: Gynecologic Oncology Group
People needed: 64
Starts: 2007-10-09
Expected to finish: 2015-06-25
Last updated by the study team: 2017-08-24

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patients who have had hydatidiform mole treated by evacuation and/or curettage and now meet the criteria of low risk GTN, as defined by the International Federation of Gynecology and Obstetrics (F.I.G.O.)/World Health Organization (W.H.O.) 2002 staging and risk scoring criteria:
A plateau in the beta-hCG assay for 4 consecutive weekly levels over a period of 3 weeks or longer; that is, days 1, 7, 14, 21; for this study, a plateau will be defined as less than a 10% decline using as a reference the initial value in the series of values taken over a period of 3 weeks; OR
A rise in the beta-hCG assay of 3 consecutive measurements, or longer, over at least a period of 2 weeks or more; days, 1, 7, 14; for this study, a rise will be defined as an increase of greater than 20% taking as a reference the initial value in the series of values taken over the 2-week period; OR
When the beta-hCG level remains elevated above normal for 6 months or longer
Patients must have a clinically significant elevated beta-hCG level of greater than 20 mIU/ml
Patients must have non-metastatic low risk GTN with a W.H.O. 2002 risk score of no greater than 6
Patients must have no metastatic disease as determined by the pelvic examination, pelvic ultrasound, and chest x-ray
Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Patients must have a Gynecologic Oncology Group (GOG) performance status of 0 or 1
Patients must have histologically confirmed complete or partial mole
Patients must agree to use an accepted method of contraception (oral contraceptives, birth control patches, Depo-Provera, diaphragm, contraceptive foam and condom, or male/female sterilization)
Patients must meet pre-entry requirements

You may not qualify if…

Patients who do not have persistent low-risk GTN
Patients with any evidence of metastatic disease beyond the uterus
Patients with persistent or recurrent GTN (same gestation) that have already been treated with chemotherapy
Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, patients who have had any evidence of the other cancer present within the last 5 years or patients whose previous cancer treatment contraindicates this protocol therapy
Patients with histologically confirmed choriocarcinoma, placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) on the first curettage
Patients who refuse to use an accepted method of contraception
Patients who have had more than one curettage for the management of the current disease or who have undergone hysterectomy

Where it is running

Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California, United States
Stanford Cancer Institute — Palo Alto, California, United States
UCSF Medical Center-Mount Zion — San Francisco, California, United States
Olive View-University of California Los Angeles Medical Center — Sylmar, California, United States
Colorado Gynecologic Oncology Group — Aurora, Colorado, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
Hartford Hospital — Hartford, Connecticut, United States
The Hospital of Central Connecticut — New Britain, Connecticut, United States
Memorial University Medical Center — Savannah, Georgia, United States
Northwestern University — Chicago, Illinois, United States
Borgess Medical Center — Kalamazoo, Michigan, United States
Bronson Methodist Hospital — Kalamazoo, Michigan, United States
West Michigan Cancer Center — Kalamazoo, Michigan, United States
Women's Cancer Center of Nevada — Las Vegas, Nevada, United States
Virtua Memorial — Mount Holly, New Jersey, United States
Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
Virtua Voorhees — Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
State University of New York Downstate Medical Center — Brooklyn, New York, United States
Gynecologic Oncology Network — Greenville, North Carolina, United States
University of Cincinnati/Barrett Cancer Center — Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa — Tulsa, Oklahoma, United States
Abington Memorial Hospital — Abington, Pennsylvania, United States

Full record on ClinicalTrials.gov

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