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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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,
Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome: Rate of acute grade 3-5 toxicities following carboplatin/gemcitabine hydrochloride and SBRT treatment graded based on CTCAE, version 4.0 [ Time Frame: Within 30 days of completing treatment ]

A modified Fibonacci design used during the dose-finding portion of this study. When =< 1 out of 6 patients enter at highest next dose level below the maximum tolerated dose (MTD), this is the recommended phase 2 dose. At least 6 patients must be entered at the recommended phase 2 dose.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression‐free survival [ Time Frame: From the time from registration until time of progression, recurrence, or death, up to 6 months ]
    Calculated following the method of Kaplan and Meier and survival dependence on measured covariates will be assessed using the Cox proportional hazards model.
  • Survival dependence on measured covariates [ Time Frame: Up to 5 years ]
    Descriptive and tabular data will be reported. Assessed using the Cox proportional hazards model.


Original Secondary Outcome: Same as current

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: July 26, 2012
Date Started: May 2012
Date Completion:
Last Updated: August 3, 2015
Last Verified: August 2015