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A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma

NCT00231868 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-08-12

Study results available
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Summary

Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution with the sequential use of radiation "sandwiched" between paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy, two of which required a 1 week treatment delay. There were no cases of grade 3 or 4 thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median follow up of 15 months, we have not observed late toxicities.

Given these favorable preliminary findings, supported by recently published data documenting efficacy of the "sandwich" multimodality technique in other difficult uterine malignancies (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible benefits in progression-free and overall survival.

Conditions

  • Uterine Cancer

Interventions

DRUG

Carboplatin and Paclitaxel and Pelvic Radiation Therapy

Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles

PROCEDURE

Carboplatin and Paclitaxel and Pelvic Radiation Therapy

Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles

DRUG

Carboplatin and Paclitaxel and Radiation Therapy

Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Mark H Einstein, M.D., M.S. · Montefiore Medical Center and Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00231868 on ClinicalTrials.gov