Papillary Serous Carcinoma of the Endometrium

This study has been completed.
Sponsor:
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
  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:

  1. Patient must undergo surgical staging within 8 weeks of study entry.
  2. Patients with mixed histology tumor that include a papillary serous component are eligible.
  3. Only patients with non-measurable disease can be entered.
  4. Patients may not have had previous chemotherapy or radiation therapy.
  5. Patients must have an estimated life expectancy of 12 weeks or greater.
  6. Patients must have a Zubrod performance status of less than or equal to 2.
  7. 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.
  8. Patients must sign an institutionally approved consent form

Exclusion Criteria:

  1. Previously treated papillary serous carcinoma with either chemotherapy or radiation therapy.
  2. Newly diagnosed papillary serous carcinoma of the endometrium, Stage IIIB-IV (patients with disease outside the pelvis).
  3. 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.
  4. Patients with a Zubrod status of 3 or greater.
  5. Patients with an active infection.
  6. Patients with serious intercurrent medical illness.
  7. 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
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 April 16, 2014