Phase 2
N=30
Papillary Serous Carcinoma of the Endometrium
Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00515073 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Jul 2014
Primary outcome: Primary: Overall Survival at 2 Years and 5 Years — 93; 85 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug); Pelvic Radiation (Radiation); Dexamethasone (Drug); Cimetidine (Drug); Diphenhydramine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at 2 Years and 5 Years |
93; 85 | — |
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.
Eligibility 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 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
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.
Data sourced from ClinicalTrials.gov (NCT00515073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.