Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00005830
First received: June 2, 2000
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: cisplatin
Drug: doxorubicin hydrochloride
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 53
Study Start Date: July 2000
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.
  • Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial cancer including 1 of the following subtypes:

    • Clear cell carcinoma
    • Serous papillary carcinoma
    • Endometrioid adenocarcinoma
  • Stage III or IV disease

    • Positive adnexa
    • Metastases to serosa, bowel mucosa, abdomen
    • Positive pelvic or paraaortic nodes
    • Positive pelvic washings or vaginal involvement within the radiation port
  • Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry

    • Must have had a hysterectomy and bilateral salpingo oophorectomy
  • No recurrent disease
  • No distant metastases outside of abdominopelvic area, including:

    • Parenchymal liver metastases
    • Lung metastases
    • Positive inguinal lymph nodes
    • Positive supraclavicular nodes
    • Pleural effusion with malignant cytology

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and alkaline phosphatase no greater than 3 times ULN

Renal:

  • Creatinine no greater than ULN

Cardiovascular:

  • Cardiac ejection fraction greater than 50%

Other:

  • No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior pelvic or abdominal radiotherapy
  • No prior radiotherapy for other prior malignancy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005830

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Jeffrey M. Fowler, MD Ohio State University Comprehensive Cancer Center
Study Chair: Perry W. Grigsby, MD St. Louis Children's Hospital
  More Information

Additional Information:
Publications:
Fowler JM, Brady WE, Cohn DE, et al.: Sequential chemotherapy and irradiation in advanced-stage endometrial cancer: a Gynecologic Oncology Group phase I trial of doxorubicin-cisplatin followed by whole-abdomen irradiation. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-230, 2007.

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00005830     History of Changes
Other Study ID Numbers: GOG-9908, CDR0000067844, NCI-2012-02332
Study First Received: June 2, 2000
Last Updated: August 19, 2013
Health Authority: United States: Federal Government
United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
stage III endometrial carcinoma
stage IV endometrial carcinoma
endometrial papillary serous carcinoma
endometrial clear cell carcinoma
endometrial adenocarcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Cisplatin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on April 15, 2014