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Dactinomycin or Methotrexate ...

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

Last Updated: 2022-08-12

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-18

Study Completion Date

2020-07-17

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. 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:

I. 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.

V. 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.

Conditions

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Choriocarcinoma FIGO Stage I Gestational Trophoblastic Tumor FIGO Stage II Gestational Trophoblastic Tumor FIGO Stage III Gestational Trophoblastic Tumor Hydatidiform Mole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (dactinomcin)

Patients receive dactinomycin IV over 15 minutes on day 1.

Group Type EXPERIMENTAL

Dactinomycin

Intervention Type BIOLOGICAL

Given IV

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm II (leucovorin calcium and methotrexate)

Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.

Group Type ACTIVE_COMPARATOR

Leucovorin Calcium

Intervention Type DRUG

Given PO

Methotrexate

Intervention Type DRUG

Given IV and IM

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Dactinomycin

Given IV

Intervention Type BIOLOGICAL

Leucovorin Calcium

Given PO

Intervention Type DRUG

Methotrexate

Given IV and IM

Intervention Type DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Actinomycin A IV Actinomycin C1 Actinomycin D Actinomycin I1 Actinomycin IV Actinomycin X 1 Actinomycin-[thr-val-pro-sar-meval] Cosmegen DACT Dactinomycine Lyovac Cosmegen Meractinomycin Adinepar Calcifolin Calcium (6S)-Folinate Calcium Folinate Calcium Leucovorin Calfolex Calinat Cehafolin Citofolin Citrec Citrovorum Factor Cromatonbic Folinico Dalisol Disintox Divical Ecofol Emovis Factor, Citrovorum Flynoken A Folaren Folaxin FOLI-cell Foliben Folidan Folidar Folinac Folinate Calcium folinic acid Folinic Acid Calcium Salt Pentahydrate Folinoral Folinvit Foliplus Folix Imo Lederfolat Lederfolin Leucosar leucovorin Rescufolin Rescuvolin Tonofolin Wellcovorin Abitrexate Alpha-Methopterin Amethopterin Brimexate CL 14377 CL-14377 Emtexate Emthexat Emthexate Farmitrexat Fauldexato Folex Folex PFS Lantarel Ledertrexate Lumexon Maxtrex Medsatrexate Metex Methoblastin Methotrexate LPF Methotrexate Methylaminopterin Methotrexatum Metotrexato Metrotex Mexate Mexate-AQ MTX Novatrex Rheumatrex Texate Tremetex Trexeron Trixilem WR-19039 Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julian C Schink

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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