NCT01652794

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

A Phase 1 Study of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine maximum tolerated carboplatin/gemcitabine dose administered with SBRT as measured by \< 30-day acute toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. SECONDARY OBJECTIVES: I. Off-study SBRT target local control assessment: 6-week post-trial fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) or other imaging response by European Organisation for Research and Treatment of Cancer (EORTC) PET criteria as listed and National Cancer Institute (NCI) guidelines. II. Off-treatment late toxicity assessment: record 3-month and 6-month radiation-related toxicity defined by CTCAE v4.0. III. Off-study global clinical benefit assessment: 6-month post-therapy clinical benefit (defined as percentage of patients who had complete, partial, or stable disease for at least 6 months). TERTIARY OBJECTIVES: I. Associate pretherapy tumor biopsy ribonucleotide reductase (R1, R2, p53R2), Tip60 and Poly(ADP-ribose) polymerase 1/2 expression with 6-week therapy response. OUTLINE: This is a dose-escalation study of carboplatin and gemcitabine hydrochloride. Patients also receive carboplatin intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.

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

Type	Name	Description
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• Completion: 2015-03-01
• First posted: 2012-07-30
• Last updated: 2015-08-04

Locations

1 site across 1 country: United States