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
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 4, 2015
August 1, 2015
2 years
July 26, 2012
August 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of acute grade 3-5 toxicities following carboplatin/gemcitabine hydrochloride and SBRT treatment graded based on CTCAE, version 4.0
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.
Within 30 days of completing treatment
Secondary Outcomes (2)
Progression-free survival
From the time from registration until time of progression, recurrence, or death, up to 6 months
Survival dependence on measured covariates
Up to 5 years
Study Arms (1)
Treatment (carboplatin, gemcitabine hydrochloride, and SBRT)
EXPERIMENTALPatients also receive carboplatin IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.
Interventions
Undergo SBRT
Given IV
Given IV
Optional correlative studies
Optional correlative studies
Eligibility Criteria
You may qualify if:
- Patient has diagnosis of a persistent or recurrent gynecologic cancer
- Patient age is \> 18 years.
- Patient must have at least one abdominopelvic measurable site of disease as defined by 9.1.3;. A treatment planning 18F-FDG positron emission tomography and computed tomography scan (PET/CT; whole body) may be used to complement assessment, \& if done must be completed prior to first dose of carboplatin / gemcitabine and within 35 days of first day of SBRT. There MUST BE no more than four (4) intended radiosurgical target lesions. An individual (one of up to four) radiosurgical target lesion MUST NOT EXCEED a volume of no greater than 160 cubic centimeters (cc).
- No prior cryosurgery or radiofrequency ablation in SBRT-target lesion. Patients with prior cryoablation and radiofrequency ablation are excluded as these treatments are designed to destroy tissue with freezing or heat. Radiation treatments given by SBRT may not work biologically or may cause excessive tissue injury in patients who have had prior cryoablation and radiofrequency ablation.
- Patient has no major medical illnesses or psychiatric illnesses:
- 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.
- Patient must have no known brain metastases. These patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound neurological and other adverse event evaluation.
- Patient must demonstrate adequate organ function (\< 35 days from enrollment):
- Bone marrow: absolute neutrophil count (ANC) ≥ 1500/mcl, platelets ≥ 100,000, hemoglobin ≥ 10 mg/dL.
- +5 more criteria
You may not qualify if:
- Any patient NOT meeting the above criteria
- Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded; patients with active connective tissue disease are at an excessive risk of organ function-impairing fibrosis
- Any patient with active Crohn's disease or active ulcerative colitis is excluded; patients having these conditions are at an excessive risk of organ function-impairing fibrosis
- Any patient with known anaphylaxis to carboplatin or gemcitabine is excluded
- Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects; screening beta-human chorionic gonadotropin (hcg) levels (urine or blood) and diagnostic tests will be used to determine eligibility in women of childbearing potential; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; these potential risks may also apply to carboplatin/gemcitabine chemotherapy agents used in this study
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with carboplatin or gemcitabine; in addition, patients known to be HIV-positive patient are excluded due to an increased risk of lethal infections when treated with marrow-suppressive therapy such as carboplatin/gemcitabine; HIV testing is not mandatory for eligibility evaluation
- Due to a perceived increased risk to transplanted organ for lethal dysfunction or lethal infection, patients with visceral organ transplants are not eligible
- Patients with other active non-gynecologic invasive malignancies are excluded; patients with other invasive malignancies who had (or have) cancer present within the last two years are excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Waggoner, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2012
First Posted
July 30, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2014
Study Completion
March 1, 2015
Last Updated
August 4, 2015
Record last verified: 2015-08