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

Not Recruiting

Trial ID: NCT00521118

Purpose

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.

Official Title

A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-metastatic Gestational Trophoblastic Neoplasia

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor

Eligibility

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Intervention(s):

other: laboratory biomarker analysis

procedure: Therapeutic Conventional Surgery

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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