A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-Day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia
- 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.
- To describe the frequency of post protocol surgical treatment for each arm.
- To describe the frequency of post protocol multi-agent chemotherapy treatment for each
- To compare multi-day methotrexate to dactinomycin with respect to frequency and
severity of adverse events in patients with low-risk gestational trophoblastic
- 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.
- To assess whether uterine artery pulsatility index (UAPI) can provide independent
prognostic information predictive of single-drug resistance.
OUTLINE: This is a multicenter study. Patients are stratified by country where treatment is
given, and multi-day methotrexate regimen (5 days vs 8 days). Patients are randomized to 1
of 2 treatment arms.
- Arm I: 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.
- Arm II: Patients receive dactinomycin IV over 15 minutes on day 1. In both arms,
treatment repeats every 14 days for up to 13 courses* in the absence of disease
progression or unacceptable toxicity.
Patients complete the Functional Assessment of Cancer Therapy (FACT-G) surveys at baseline,
during, and after completion of study treatment.
Patients may undergo Doppler ultrasound to measure the left and right uterine artery
pulsatility indices (UAPI) at baseline.
After completion of study treatment, patients are followed up every 3 months for 2 years.
NOTE: * Patients will be treated for three courses after 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Complete response vs treatment failure
Julian C. Schink, MD
Robert H. Lurie Cancer Center
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus||New Britain, Connecticut 06050|
|Mercy Medical Center - Sioux City||Sioux City, Iowa 51104|
|Siouxland Hematology-Oncology Associates, LLP||Sioux City, Iowa 51101|
|St. Luke's Regional Medical Center||Sioux City, Iowa 51104|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center||Milwaukee, Wisconsin 53201-2901|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|St. John's Regional Health Center||Springfield, Missouri 65804|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Northeast Georgia Medical Center||Gainesville, Georgia 30501|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center||Green Bay, Wisconsin 54311|
|Fox Chase Cancer Center CCOP Research Base||Philadelphia, Pennsylvania 19140|
|Gynecologic Oncology||Hinsdale, Illinois 60521|
|Aurora Women's Pavilion of West Allis Memorial Hospital||West Allis, Wisconsin 53227|
|Mercy Clinic Cancer and Hematology - Rolla||Rolla, Missouri 65401|