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

Primary Purpose

Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Doxorubicin Hydrochloride
Cisplatin
Radiation Therapy
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater than 3 times ULN Creatinine no greater than ULN Cardiac ejection fraction greater than 50% No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer No prior chemotherapy No prior pelvic or abdominal radiotherapy No prior radiotherapy for other prior malignancy

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (doxorubicin, cisplatin, radiation therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients completing the prescribed therapy
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0
Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0

Secondary Outcome Measures

Reason for discontinuing study therapy

Full Information

First Posted
June 2, 2000
Last Updated
December 29, 2014
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005830
Brief Title
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Official Title
Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (doxorubicin, cisplatin, radiation therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin Hydrochloride
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT
Intervention Description
Undergo radiation therapy
Primary Outcome Measure Information:
Title
Number of patients completing the prescribed therapy
Time Frame
Up to 9 weeks
Title
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0
Time Frame
3 weeks
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Reason for discontinuing study therapy
Time Frame
Up to 9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater than 3 times ULN Creatinine no greater than ULN Cardiac ejection fraction greater than 50% No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer No prior chemotherapy No prior pelvic or abdominal radiotherapy No prior radiotherapy for other prior malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Fowler
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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