Study Stopped
Funding source withdrew funding
Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer
A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer
4 other identifiers
interventional
N/A
1 country
1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin together with carboplatin may kill more tumor cells. PURPOSE: This phase I and phase II trial is studying the side effects and best dose of carboplatin when given together with doxorubicin to see how well it works in treating patients with recurrent ovarian cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2008
Shorter than P25 for phase_1 ovarian-cancer
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
First Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 21, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedNovember 20, 2017
October 1, 2017
10 months
November 20, 2007
November 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Acute toxicity
Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I)
Primary efficacy and safety (phase II)
Interventions
Eligibility Criteria
You may qualify if:
- GOG performance status 0, 1, or 2
- Life expectancy \> 6 months
- Absolute neutrophil count ≥ 1,500/uL
- Platelet count ≥ 100,000/uL
- Hemoglobin \> 9.0 g/dL
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- SGOT and alkaline phosphatase ≤ 3 x ULN
- Neuropathy (sensory and motor) ≤ CTCAE grade 1
You may not qualify if:
- GOG performance status 3 or 4
- Pregnant or breastfeeding
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of DOXIL®
- Abnormal LVEF as determined by gated cardiac radionucleotide scan (MUGA)
- Septicemia or severe infection
- Acute hepatitis or severe gastrointestinal bleeding
- Any of the following:
- Unstable angina
- Myocardial infarction within the past 6 months
- NYHA class II-IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Clinically significant pericardial disease
- Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jayanthi S. Lea, MD
Simmons 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
November 20, 2007
First Posted
November 21, 2007
Study Start
May 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
November 20, 2017
Record last verified: 2017-10