Papillary Serous Carcinoma of the Endometrium
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00515073
First received: August 9, 2007
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: Paclitaxel Radiation: Pelvic Radiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Overall Survival [ Time Frame: 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) ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | April 2001 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paclitaxel (Taxol) + Pelvic Radiation
Paclitaxel (Taxol) 50 mg/m^2 IV Weekly Over 1 Hour x 5 Weeks. Radiation therapy to the pelvis daily for 25 treatments.
|
Drug: Paclitaxel
50 mg/m^2 IV Weekly Over 1 Hour x 5 Weeks
Other Name: Taxol
Radiation: Pelvic Radiation
Radiation therapy to the pelvis daily for 25 treatments.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 WBC greater than or equal to 3000; ANC greater than or equal to 1500; Platelets greater than or equal to 100,000; SGPT less than or equal to 2x the upper limit of normal; Total bilirubin less than or equal to 2.5mg/dl.
- Patients must sign an institutionally approved consent form
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515073
Locations
| United States, Florida | |
| M. D. Anderson Cancer Center - Orlando | |
| Orlando, Florida, United States, 32806 | |
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Anuja Jhingran, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00515073 History of Changes |
| Other Study ID Numbers: | ID00-418 |
| Study First Received: | August 9, 2007 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Endometrial Cancer Papillary Serous Carcinoma Pelvic Radiation Therapy Paclitaxel Taxol |
Additional relevant MeSH terms:
|
Carcinoma Endometrial Neoplasms Cystadenocarcinoma, Serous Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female |
Cystadenocarcinoma Adenocarcinoma Neoplasms, Cystic, Mucinous, and Serous Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013