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

NCT00448643 | Completed Phase 1 DMC

• 3 other identifiers: 20020138SCCC-2001064WIRB-20050721
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

endometrial adenocarcinoma; endometrial clear cell carcinoma; endometrial papillary carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma

Outcome Measures

Primary Outcomes (2)

• Toxicity as assessed by GOG Common Toxicity Criteria

  Study duration

• Recommended phase II dose of whole-abdominal radiotherapy

  Study duration

Study Arms (1)

Whole-Abdominal Radiation Therapy and Chemotherapy

EXPERIMENTAL

Radiation: Vaginal Brachytherapy; Drug: Cisplatin; Radiation: Whole Abdominal Radiation [WAR] Therapy

Interventions

Vaginal Brachytherapy RADIATION

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

Whole-Abdominal Radiation Therapy and Chemotherapy

Cisplatin DRUG

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

Whole-Abdominal Radiation Therapy and Chemotherapy

Whole Abdominal Radiation [WAR] Therapy RADIATION

Whole Abdominal Radiation Therapy, Dose Escalated \[2-Levels\]; 6 -8 hours after administration of Cisplatin chemotherapy

Also known as: WAR

Whole-Abdominal Radiation Therapy and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Cisplatin; Therapeutics

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Aaron H. Wolfson, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: May 1, 2002
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)