Clinical trial NCT00003688: Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Official title: Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gestational Trophoblastic Tumor
Keywords: recurrent gestational trophoblastic tumor
nonmetastatic gestational trophoblastic tumor
low risk metastatic gestational trophoblastic tumor
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Los Gatos
country: United States
facility: Community Hospital of Los Gatos
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
state: California
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Lexington
country: United States
facility: Albert B. Chandler Medical Center, University of Kentucky
state: Kentucky
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: State University of New York Health Science Center at Brooklyn
state: New York
city: Stony Brook
country: United States
facility: Long Island Cancer Center at Stony Brook University Hospital
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Charles M. Barrett Cancer Center at University Hospital
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Brookview Research, Inc.
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
Study officials:
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Allan Covens, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1002/cncr.22118.