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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

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ClinicalTrials.gov Identifier: NCT00448643
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
University of Miami

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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: Vaginal Brachytherapy Drug: Cisplatin Radiation: Whole Abdominal Radiation [WAR] Therapy Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium
Study Start Date : May 2002
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Whole-Abdominal Radiation Therapy and Chemotherapy Radiation: Vaginal Brachytherapy
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
Drug: Cisplatin
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
Radiation: Whole Abdominal Radiation [WAR] Therapy
Whole Abdominal Radiation Therapy, Dose Escalated [2-Levels]; 6 -8 hours after administration of Cisplatin chemotherapy
Other Name: WAR



Primary Outcome Measures :
  1. Toxicity as assessed by GOG Common Toxicity Criteria [ Time Frame: Study duration ]
  2. Recommended phase II dose of whole-abdominal radiotherapy [ Time Frame: Study duration ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448643


Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Study Chair: Aaron H. Wolfson, MD University of Miami Sylvester Comprehensive Cancer Center

Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT00448643     History of Changes
Other Study ID Numbers: 20020138
SCCC-2001064
WIRB-20050721
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016

Keywords provided by University of Miami:
endometrial adenocarcinoma
endometrial clear cell carcinoma
endometrial papillary carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents