A Phase 1 interventional study of Doxorubicin Hydrochloride and Cisplatin in Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma and Endometrial Serous Adenocarcinoma, sponsored by Gynecologic Oncology Group. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-31.
Sponsored by Gynecologic Oncology Group · Phase 1, Interventional, and Treatment
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.
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 31 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Histologically confirmed endometrial cancer including 1 of the following subtypes:
Stage III or IV disease
Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry
No distant metastases outside of abdominopelvic area, including:
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.
Drug: Doxorubicin Hydrochloride · Drug: Cisplatin · Radiation: Radiation Therapy
Given IV
Given IV
Undergo radiation therapy
Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT
Number of patients completing the prescribed therapy
Time frame: Up to 9 weeks
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0
Time frame: 3 weeks
Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0
Time frame: Up to 5 years after completion of study treatment
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0
Time frame: Up to 9 weeks
Reason for discontinuing study therapy
Time frame: Up to 9 weeks
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Gynecologic Oncology Group