CompletedPhase 1

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

United States12 participantsStarted 2012-05

Plain-language 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.

Who can participate

Age range19 Years

SexFEMALE

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Inclusion criteria

✓. New York Heart Association (NYHA) class 3 or 4 congestive heart failure;
✓. unstable angina pectoris;
✓. symptomatic cardiac arrhythmia;
✓. hypertension with diastolic blood pressure greater than 110 mmHg;
✓. pulmonary disease consisting of dyspnea at rest requiring oxygen supplementation;
✓. renal function impairment (defined here as baseline serum creatinine \>2.0 mg/dL);
✓. psychiatric illness/social situations that would limit compliance.

What they're measuring

Rate of acute grade 3-5 toxicities following carboplatin/gemcitabine hydrochloride and SBRT treatment graded based on CTCAE, version 4.0

Timeframe: Within 30 days of completing treatment

Trial details

NCT IDNCT01652794

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-05

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