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Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer

NCT01652794 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-08-04

No results posted yet for this study

Summary

The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.

Conditions

  • Leydig Cell Tumor
  • Ovarian Sarcoma
  • Ovarian Stromal Cancer
  • Pseudomyxoma Peritonei
  • Recurrent Cervical Cancer
  • Recurrent Endometrial Carcinoma
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Primary Peritoneal Cavity Cancer
  • Recurrent Uterine Sarcoma
  • Recurrent Vaginal Cancer
  • Recurrent Vulvar Cancer

Interventions

RADIATION

stereotactic body radiation therapy

Undergo SBRT

DRUG

carboplatin

Given IV

DRUG

gemcitabine hydrochloride

Given IV

OTHER

laboratory biomarker analysis

Optional correlative studies

OTHER

pharmacogenomic studies

Optional correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Steven Waggoner, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-05-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01652794 on ClinicalTrials.gov