Papillary Serous Carcinoma of the Endometrium

NCT00515073 | Completed Phase 2 Results

• 1 other identifier: ID00-418
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objectives:

• To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary serous carcinoma of the endometrium for both local control and overall survival.
• To evaluate the toxicity of Paclitaxel and pelvic radiation.
• To collect and evaluate patients' quality of life/symptom assessment data.

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; Papillary Serous Carcinoma; Pelvic Radiation Therapy; Paclitaxel; Taxol

Outcome Measures

Primary Outcomes (1)

• Overall Survival at 2 Years and 5 Years

  The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.

  Assessment at 2 years and 5 years

Study Arms (1)

Paclitaxel (Taxol) + Pelvic Radiation

EXPERIMENTAL

Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.

Drug: Paclitaxel; Radiation: Pelvic Radiation; Drug: Dexamethasone; Drug: Cimetidine; Drug: Diphenhydramine

Interventions

Paclitaxel DRUG

50 mg/m\^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m\^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.

Also known as: Taxol

Paclitaxel (Taxol) + Pelvic Radiation

Pelvic Radiation RADIATION

Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.

Paclitaxel (Taxol) + Pelvic Radiation

Dexamethasone DRUG

20 mg IV given 30 minutes prior to chemotherapy

Paclitaxel (Taxol) + Pelvic Radiation

Cimetidine DRUG

300 mg IV given 30 minutes prior to chemotherapy

Paclitaxel (Taxol) + Pelvic Radiation

Diphenhydramine DRUG

50 mg IV given 30 minutes prior to chemotherapy

Paclitaxel (Taxol) + Pelvic Radiation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must undergo surgical staging within 8 weeks of study entry.
• Patients with mixed histology tumor that include a papillary serous component are eligible.
• Only patients with non-measurable disease can be entered.
• Patients may not have had previous chemotherapy or radiation therapy.
• Patients must have an estimated life expectancy of 12 weeks or greater.
• Patients must have a Zubrod performance status of less than or equal to 2.
• Patients must have adequate bone marrow, renal and hepatic function: with white blood count (WBC) greater than or equal to 3000; Absolute neutrophil count (ANC) greater than or equal to 1500; Platelets greater than or equal to 100,000; glutamic-pyruvic transaminase (SGPT) less than or equal to 2 times the upper limit of normal; Total bilirubin less than or equal to 2.5mg/dl.
• Patients must sign an institutionally approved consent form

You may not qualify if:

• Previously treated papillary serous carcinoma with either chemotherapy or radiation therapy.
• Newly diagnosed papillary serous carcinoma of the endometrium, Stage IIIB-IV (patients with disease outside the pelvis).
• Patients who have a history of other malignancy, with the exception of non-melanomatous skin cancer, unless in complete remission and off all therapy for that disease for a minimum of 5 years.
• Patients with a Zubrod status of 3 or greater.
• Patients with an active infection.
• Patients with serious intercurrent medical illness.
• Patients with a recent (within 6 months) history of congestive heart failure, unstable angina or myocardial infarction.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

M. D. Anderson Cancer Center - Orlando

Orlando, Florida, 32806, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Jhingran A, Ramondetta LM, Bodurka DC, Slomovitz BM, Brown J, Levy LB, Garcia ME, Eifel PJ, Lu KH, Burke TW. A prospective phase II study of chemoradiation followed by adjuvant chemotherapy for FIGO stage I-IIIA (1988) uterine papillary serous carcinoma of the endometrium. Gynecol Oncol. 2013 May;129(2):304-9. doi: 10.1016/j.ygyno.2013.01.025. Epub 2013 Feb 4.

  PMID: 23385150 RESULT

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms; Cystadenocarcinoma, Serous

Interventions

Paclitaxel; Dexamethasone; Cimetidine; Diphenhydramine

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; Cystadenocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Guanidines; Amidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic

Results Point of Contact

• Title: Anuja Jhingran, MD / Professor, Radiation Oncology Department
• Organization: University of Texas MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-563-6900

Study Officials

• Anuja Jhingran, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: April 1, 2001
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 3, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-05

Locations

US (2)