Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	12 to 50	NCI	GOG-176 NCT00003688, GOG-0176

Objectives

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

Entry 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

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

Patient Characteristics:

Age

• 12 to 50

Performance status

• GOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• Granulocyte count at least 1,500/mm³

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

Expected Enrollment

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

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.

Covens A, Filiaci VL, Burger RA, et al.: Phase II trial of pulse dactinomycin as salvage therapy for failed low-risk gestational trophoblastic neoplasia: a Gynecologic Oncology Group study. Cancer 107 (6): 1280-6, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Allan Covens, MD, Protocol chair		Ph: 416-480-4026 Email: al.covens@sunnybrook.ca

Registry Information
Official Title		Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
Trial Start Date		1999-10-18
Registered in ClinicalTrials.gov		NCT00003688
Date Submitted to PDQ		1998-12-10
Information Last Verified		2003-12-10
NCI Grant/Contract Number		CA27469

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