Methotrexate or Dactinomycin in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
This study is currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01535053
First received: February 14, 2012
Last updated: October 17, 2012
Last verified: October 2012
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Purpose
RATIONALE: 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 or by stopping them from dividing. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.
PURPOSE: This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia.
| Condition | Intervention | Phase |
|---|---|---|
|
Gestational Trophoblastic Tumor |
Biological: dactinomycin Drug: methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-Day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Complete response vs treatment failure [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Severity of adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4 [ Designated as safety issue: Yes ]
- Overall QOL [ Designated as safety issue: No ]
- Factors to be tested for association with treatment failure: WHO risk score, choriocarcinoma histology, uterine artery pulsatility index [ Designated as safety issue: No ]
| Estimated Enrollment: | 384 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: methotrexate
Given IV or IM
|
|
Active Comparator: Arm II
Patients receive dactinomycin IV over 15 minutes on day 1.
|
Biological: dactinomycin
Given IV
|
Detailed Description:
OBJECTIVES:
Primary
- 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
- 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 arm.
- To compare multi-day methotrexate to dactinomycin with respect to frequency and severity of adverse events in patients with low-risk gestational trophoblastic neoplasia.
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
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; 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 1 criterion for GTN defined as:
- A < 10% decrease in the human chorionic gonadotropin (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)
- 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)
- A persistently elevated hCG level for a period of 6 months or more following the initial curettage (> 50 mIU/mL minimum)
Choriocarcinoma meeting 1 of the following criteria:
- Histologically proven non-metastatic choriocarcinoma
- 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
- No patients with non-gestational choriocarcinoma
- No patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
PATIENT CHARACTERISTICS:
- Patients must be willing to practice effective contraception for the duration of the study
- White blood cell (WBC) ≥ 3,000 cells/mcL
- Granulocytes ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Creatinine ≤ 2.0 mg/dcL
- Bilirubin ≤ 1.5 times institutional normal
- ALT and AST ≤ 3 times institutional normal
- Alkaline phosphatase ≤ 3 times institutional normal
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- 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
- No patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
- No patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
- No patients who wish to breast-feed during treatment
PRIOR CONCURRENT THERAPY:
No patients who have previously been treated with cytotoxic chemotherapy
- Patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
- No patients who have received prior pelvic radiation
- Patients are excluded if their previous cancer treatment contraindicates this protocol therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535053
Locations
| United States, Connecticut | |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | Recruiting |
| New Britain, Connecticut, United States, 06050 | |
| Contact: Clinical Trials Office - George Bray Cancer Center 860-224-5660 | |
| United States, Georgia | |
| Northeast Georgia Medical Center | Recruiting |
| Gainesville, Georgia, United States, 30501 | |
| Contact: Andrew E. Green 770-535-3553 | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Recruiting |
| Savannah, Georgia, United States, 31403-3089 | |
| Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer 912-350-8568 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
| Gynecologic Oncology | Recruiting |
| Hinsdale, Illinois, United States, 60521 | |
| Contact: Sudarshan K. Sharma, MD 630-856-6757 | |
| United States, Iowa | |
| Mercy Medical Center - Sioux City | Recruiting |
| Sioux City, Iowa, United States, 51102 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| Siouxland Hematology-Oncology Associates, LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| St. Luke's Regional Medical Center | Recruiting |
| Sioux City, Iowa, United States, 51104 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| United States, Missouri | |
| Mercy Clinic Cancer and Hematology - Rolla | Recruiting |
| Rolla, Missouri, United States, 65401 | |
| Contact: Robert L. Carolla 573-458-6379 | |
| CCOP - Cancer Research for the Ozarks | Recruiting |
| Springfield, Missouri, United States, 65802 | |
| Contact: Robert L. Carolla 417-269-4520 | |
| St. John's Regional Health Center | Recruiting |
| Springfield, Missouri, United States, 65804 | |
| Contact: Robert L. Carolla 417-820-2000 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| United States, Ohio | |
| Summa Center for Cancer Care at Akron City Hospital | Recruiting |
| Akron, Ohio, United States, 44309-2090 | |
| Contact: Clinical Trials Office - Akron City Hospital 330-375-6101 | |
| Riverside Methodist Hospital Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43214-3998 | |
| Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| Cancer Care Associates - Saint Francis Campus | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| United States, Pennsylvania | |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M 215-481-2402 | |
| Fox Chase Cancer Center CCOP Research Base | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Clinical Trials Office - Fox Chase Cancer Center CCOP Research 215-728-2983 | |
| United States, Wisconsin | |
| Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | Recruiting |
| Green Bay, Wisconsin, United States, 54311 | |
| Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic - Green 414-649-5717 | |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic 414-649-5717 | |
| Aurora Women's Pavilion of West Allis Memorial Hospital | Recruiting |
| West Allis, Wisconsin, United States, 53227 | |
| Contact: Peter Johnson, MD 262-549-6662 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Principal Investigator: | Julian C. Schink, MD | Robert H. Lurie Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01535053 History of Changes |
| Other Study ID Numbers: | CDR0000725211, GOG-0275 |
| Study First Received: | February 14, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
gestational trophoblastic tumor hydatidiform mole low risk metastatic gestational trophoblastic tumor uterine choriocarcinoma |
stage I gestational trophoblastic tumor stage II gestational trophoblastic tumor stage III gestational trophoblastic tumor |
Additional relevant MeSH terms:
|
Neoplasms Trophoblastic Neoplasms Gestational Trophoblastic Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Pregnancy Complications, Neoplastic Pregnancy Complications Dactinomycin Methotrexate Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Anti-Bacterial Agents Anti-Infective Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013