Trials / Completed
CompletedNCT00005830
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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. 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.
Detailed description
OBJECTIVES: I. Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer. II. 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.
Conditions
- Endometrial Adenocarcinoma
- Endometrial Clear Cell Adenocarcinoma
- Endometrial Serous Adenocarcinoma
- Stage III Uterine Corpus Cancer
- Stage IV Uterine Corpus Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Doxorubicin Hydrochloride | Given IV |
| DRUG | Cisplatin | Given IV |
| RADIATION | Radiation Therapy | Undergo radiation therapy |
Timeline
- Start date
- 2000-07-01
- Primary completion
- 2009-07-01
- First posted
- 2003-01-27
- Last updated
- 2014-12-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00005830. Inclusion in this directory is not an endorsement.