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Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma


Phase 1
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jeffrey M. Fowler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067844

NCT ID:

NCT00005830

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • endometrial papillary serous carcinoma
  • endometrial clear cell carcinoma
  • endometrial adenocarcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Lake/University Ireland Cancer CenterMentor, Ohio  44060
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195