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Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vaginal Brachytherapy
Cisplatin
Whole Abdominal Radiation [WAR] Therapy
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring endometrial adenocarcinoma, endometrial clear cell carcinoma, endometrial papillary carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of endometrial cancer, including any of the following cellular types:

    • Papillary serous carcinoma
    • Clear cell carcinoma
    • Adenocarcinoma

  • Stage III or IV disease

    • No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or supraclavicular nodes)

  • Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian tube and ovary, and resection of any palpable lymph nodes in the pelvis and para-aortic region (or surgical sampling of these nodal regions if no palpable nodes were present) within the past 6 weeks

    • Peritoneal washings must have been collected for cytological evaluation
    • Must have ≤ 1 cm residual disease after surgery

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 6 months
  • WBC ≥ 3,000/mm^3
  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine < 2.0 mg/dL
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • Lactate dehydrogenase < 3 times ULN
  • Gamma glutamyl transferase < 3 times ULN
  • SGPT and SGOT < 3 times ULN
  • Alkaline phosphatase < 3 times ULN
  • No other malignant tumor within the past 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to the whole abdomen and/or pelvis/vagina
  • No systemic chemotherapy within the past 5 years

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole-Abdominal Radiation Therapy and Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Toxicity as assessed by GOG Common Toxicity Criteria
Recommended phase II dose of whole-abdominal radiotherapy

Secondary Outcome Measures

Full Information

First Posted
March 15, 2007
Last Updated
December 14, 2016
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00448643
Brief Title
Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery
Official Title
A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also make tumor cells more sensitive to cisplatin. Giving radiation therapy together with cisplatin after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal radiation therapy when given together with cisplatin in treating patients with stage III or stage IV endometrial cancer that has been removed by surgery.
Detailed Description
OBJECTIVES: Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when administered with cisplatin in patients with optimally debulked stage III or IV carcinoma of the endometrium. OUTLINE: This is a dose-escalation study of whole-abdominal radiotherapy (WAR). Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel IV. Beginning within 6 weeks after completion of standard chemotherapy, patients receive cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1. Treatment with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo standard vaginal brachytherapy beginning no earlier than the last course of standard chemotherapy or no later than 1 week before the start of cisplatin and WAR. Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose (RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the RPTD. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial adenocarcinoma, endometrial clear cell carcinoma, endometrial papillary carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Whole-Abdominal Radiation Therapy and Chemotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Vaginal Brachytherapy
Intervention Description
High-Dose Rate [HDR] or Low-Dose Rate [LDR], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Whole Abdominal Radiation [WAR] Therapy
Other Intervention Name(s)
WAR
Intervention Description
Whole Abdominal Radiation Therapy, Dose Escalated [2-Levels]; 6 -8 hours after administration of Cisplatin chemotherapy
Primary Outcome Measure Information:
Title
Toxicity as assessed by GOG Common Toxicity Criteria
Time Frame
Study duration
Title
Recommended phase II dose of whole-abdominal radiotherapy
Time Frame
Study duration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of endometrial cancer, including any of the following cellular types: Papillary serous carcinoma Clear cell carcinoma Adenocarcinoma Stage III or IV disease No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or supraclavicular nodes) Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian tube and ovary, and resection of any palpable lymph nodes in the pelvis and para-aortic region (or surgical sampling of these nodal regions if no palpable nodes were present) within the past 6 weeks Peritoneal washings must have been collected for cytological evaluation Must have ≤ 1 cm residual disease after surgery PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Life expectancy ≥ 6 months WBC ≥ 3,000/mm^3 Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Creatinine < 2.0 mg/dL Bilirubin < 1.5 times upper limit of normal (ULN) Lactate dehydrogenase < 3 times ULN Gamma glutamyl transferase < 3 times ULN SGPT and SGOT < 3 times ULN Alkaline phosphatase < 3 times ULN No other malignant tumor within the past 5 years PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy to the whole abdomen and/or pelvis/vagina No systemic chemotherapy within the past 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron H. Wolfson, MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery

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