Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003688

Purpose

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.

Condition	Intervention	Phase
Gestational Trophoblastic Tumor	Biological: dactinomycin	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Dactinomycin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 1999

Detailed 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.

Eligibility

Ages Eligible for Study:	12 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003688

Show 29 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Allan Covens, MD

Edmond Odette Cancer Centre at Sunnybrook

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Covens A, Filiaci VL, Burger RA, Osborne R, Chen MD; Gynecologic Oncology Group. Phase II trial of pulse dactinomycin as salvage therapy for failed low-risk gestational trophoblastic neoplasia: a Gynecologic Oncology Group study. Cancer. 2006 Sep 15;107(6):1280-6.

Study ID Numbers:	CDR0000066791, GOG-176
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003688 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent gestational trophoblastic tumor
nonmetastatic gestational trophoblastic tumor
good prognosis metastatic gestational trophoblastic tumor

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hydatidiform Mole
Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions

Anti-Bacterial Agents
Protein Synthesis Inhibitors
Neoplasms
Dactinomycin
Gestational Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Trophoblastic Neoplasms
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on March 18, 2010