Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Gestational Trophoblastic Tumor

Treatments: Biological: dactinomycin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003688

GOG-176

CDR0000066791

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of dactinomycin in treating patients who have persistent or recurrent gestational trophoblastic neoplasia.

Full description

OBJECTIVES:

• Determine the efficacy of dactinomycin in patients with persistent or recurrent low-risk gestational trophoblastic neoplasia.
• Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive dactinomycin IV over 15 minutes on day 1. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients who achieve normal beta-human chorionic gonadotropin (HCG) receive 2 additional courses after attaining normal beta-HCG.

Patients are followed every 2 weeks for 2 months and then monthly for 10 months.

PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within 18-42 months.

Sex: Female

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed complete or partial mole on initial evaluation

  • Current diagnosis of persistent or recurrent low-risk gestational trophoblastic neoplasia, defined by 1 of the following criteria:

    • Less than 10% fall in beta-human chorionic gonadotropin (HCG) over 3 consecutive weekly titers
    • More than 20% rise in beta-HCG over the previous value at any time
    • Rise in beta-HCG (greater than 5 mU/mL) after attaining normal level

• Prior treatment limited to methotrexate (MTX) with or without leucovorin calcium (CF)

• WHO score 2-6 at time of relapse

• Must have undergone at least 1 prior curettage for diagnosis and initial management

• No metastatic disease other than lung or vagina on physical examination, chemistry, chest x-ray, or ultrasound

• No more than 8 metastatic lesions

• No histologically confirmed placental site trophoblastic tumor at initial evaluation

PATIENT CHARACTERISTICS:

Age

• 12 to 50

Performance status

• GOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3
• Granulocyte count at least 1,500/mm^3

Hepatic

• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal
• Alkaline phosphatase no greater than 3 times normal

Renal

• Creatinine no greater than 1.5 mg/dL

Other

• No significant infection
• No more than 1 year since prior pregnancy
• Fertile patients must use effective contraception
• No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• At least 1 week since prior chemotherapy and recovered
• No prior chemotherapeutic drugs other than MTX with or without CF

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics
• Recovered from prior surgery
• No concurrent curettage unless required to control vaginal bleeding

Other

• No prior anticancer treatment that would preclude study therapy