Summary

for females ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started

Description

Summary

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

Official Title

A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia

Details

PRIMARY OBJECTIVES:

  1. To test the hypothesis that treatment with multi-day methotrexate is inferior to treatment with pulse actinomycin-D (dactinomycin) in patients with low-risk gestational trophoblastic disease with respect to complete response.

SECONDARY OBJECTIVES:

  1. To describe the frequency of post protocol surgical treatment for each arm. II. To describe the frequency of post protocol multi-agent chemotherapy treatment for each arm.

III. To compare multi-day methotrexate to actinomycin-D with respect to frequency and severity of adverse events in patients with low-risk gestational trophoblastic neoplasia.

IV. To investigate the impact of treatment on overall quality-of-life (QOL) and explore the influence of treatment on issues such as body image, sexual functioning, and patient-reported side effects and disruption.

  1. To assess whether uterine artery pulsatility index (UAPI) can provide independent prognostic information predictive of single-drug resistance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive dactinomycin intravenously (IV) over 15 minutes on day 1.

ARM II: Patients receive methotrexate intramuscularly (IM) on days 1, 3, 5, and 7 and leucovorin calcium orally (PO) on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.

In both arms, treatment repeats every 14 days for up to 20 courses* in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 1 year and then every 3 months for 1 year.

NOTE: * Patients will be treated for three courses after human chorionic gonadotropin (hCG) < 5 mIU/mL or until evidence of treatment failure (biologic progression), disease progression, or unacceptable toxicity despite dose modifications. Upon normalization of hCG (< 5 mIU/mL), patients will be treated with three additional courses.

Keywords

Choriocarcinoma FIGO Stage I Gestational Trophoblastic Tumor FIGO Stage II Gestational Trophoblastic Tumor FIGO Stage III Gestational Trophoblastic Tumor Hydatidiform Mole Trophoblastic Neoplasms Gestational Trophoblastic Disease Calcium, Dietary Methotrexate Dactinomycin Levoleucovorin Leucovorin Leucovorin Calcium Quality-of-Life Assessment

Eligibility

You can join if…

Open to females ages 18 years and up

  • Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage

I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:

  • Post molar GTN
  • For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:
  • A < 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml minimum) OR
  • A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR
  • A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)
  • Choriocarcinoma
  • Histologically proven non-metastatic choriocarcinoma OR
  • Histologically proven metastatic choriocarcinoma if the metastatic site(s)is restricted to one (or more) of the following: vagina, parametrium, or lung
  • World Health Organization (WHO) risk score 0-6
  • Patients must be willing to practice effective contraception for the duration of the study
  • White blood cell count (WBC) >= 3,000 cells/mcL
  • Granulocytes >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Creatinine =< 2.0 mg/dcL
  • Bilirubin =< 1.5 x institutional normal
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional normal
  • Alkaline phosphatase =< 3 x institutional normal
  • Patients who have met the pre-entry requirements
  • Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

You CAN'T join if...

  • Patients who do not have GTN
  • Patients with non-gestational choriocarcinoma
  • Patients who have previously been treated with cytotoxic chemotherapy; however,patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
  • Patients who have received prior pelvic radiation
  • Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
  • Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
  • Patients who wish to breast-feed during treatment

Locations

  • UC San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • Loma Linda University Medical Center
    Loma Linda California 92354 United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles California 90027 United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank California 91505 United States
  • Women's Cancer Center of Nevada
    Las Vegas Nevada 89169 United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Gynecologic Oncology Group
ID
NCT01535053
Phase
Phase 3
Study Type
Interventional
Last Updated
August 23, 2017