Study Stopped
study was never opened to accrual
Metformin Hydrochloride, Carboplatin, and Paclitaxel in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The Use and Safety of Metformin, Carboplatin and Paclitaxel in Non-Diabetic Patients With Recurrent, Platinum Sensitive Ovarian Cancer and the Feasibility of Using a Core Biopsy for RNA-Seq
4 other identifiers
interventional
N/A
1 country
1
Brief Summary
This phase I trial studies the side effects and best way to give metformin hydrochloride, carboplatin, and paclitaxel in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as metformin hydrochloride, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2014
CompletedFebruary 20, 2019
February 1, 2019
January 28, 2014
February 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Probability of successes in patients receiving the combination therapy
Success for a patient is defined as having a length of remission/progression free survival following this combination therapy that is longer than the length of remission/progression free survival resulting from their immediately prior line of treatment. A one-sided, one sample test of the binomial proportion will be conducted.
Up to 2 years
Secondary Outcomes (4)
Time to progression
Time from first documentation of recurrence, to the first documentation of progression after initiating on this trial, assessed up to 2 years
Response rate defined by the RECIST
Up to 2 years
Progression free survival
Up to 4 years
Overall survival
Up to 4 years
Study Arms (1)
Treatment (metformin hydrochloride, carboplatin, paclitaxel)
EXPERIMENTALPatients receive metformin hydrochloride BID on days 1-21, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Given IV
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v.) 1.1; for those patients in the Phase 1a portion that are agreeable, disease must be amenable to ultrasound or computed tomography (CT) guided biopsy of a lesion outside of the target lesion; patients must have histologically or cytologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer
- No antineoplastic therapy (eg, drugs, biologicals, monoclonal antibodies, etc) or radiotherapy within 6 months before enrollment; patients previously treated with antineoplastic therapy in the past must have recovered (ie, grade =\< 1 toxicity or patient's baseline status, except alopecia) from all treatment-related toxicities
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count \>= 1,500 cells/mm\^3
- Platelets \>= 100,000 cells/mm\^3
- Hemoglobin \>= 9 g/dL
- Total bilirubin =\< 1.5 times the upper limit of normal
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) (serum glutamic oxaloacetic transaminase \[SGOT\]/serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times institutional normal limits
- Creatinine =\< 1.5 for men and 1.4 for women
- Fasting blood sugar =\< 126
- Hemoglobin A1C =\< 6.5
- Patients in the Phase 1a portion of the clinical trial must have a tumor that is deemed safe to biopsy and must consent to serial biopsies and or surgical resection after treatment with metformin
- Patients must be minimally, status post bilateral salpingo-oophorectomy
- Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
- +2 more criteria
You may not qualify if:
- Patients may not be receiving any other investigational agents
- Patients must not have evidence of disease recurrence within 6 months of completing the last dose of platinum based therapy
- Patient with current diagnosis of diabetes, or currently taking insulin, metformin, sulfonylureas, or other medications used for the treatment of elevated blood sugar
- Conditions leading to increased risk of metformin induced lactic acidosis, including congestive heart failure (New York Heart Association \[NYHA\] class III or IV), history of acidosis, or daily intake of 3 or more alcoholic drinks
- Use of metformin in the past 6 months
- History of allergic reactions/hypersensitivity reactions to metformin
- History of allergic or hypersensitivity reaction to carboplatin, paclitaxel, or Cremophor® EL
- Baseline nausea \> grade 1
- Baseline evidence of metabolic acidosis, with total carbon dioxide (TCO2) of less than 20
- Patients with history of \>= grade 2 neurotoxicity or any toxicity requiring discontinuation from taxanes chemotherapy that is not resolved to =\< grade 1
- Any condition that would prohibit patient from being able to take and digest metformin, such as gastroparesis, history of malabsorption, history of baseline diarrhea, current symptoms of small bowel obstruction, current symptoms of an ileus, history of a resection of the stomach or small bowel, or history of Crohn's disease/colitis
- Current alcohol abuse: patients using more than 1 standard unit of alcohol per day for the past 30 days; a standard unit of alcohol is defined as a 12 oz beer (350 mL), 1.5 oz (45 mL) of 80-proof alcohol, or one 6-oz (175 mL) glass of wine
- Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast feeding
- Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of metformin, or other severe infection
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fox Chase Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Jain
Fox Chase 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
January 28, 2014
First Posted
January 30, 2014
Primary Completion
October 1, 2014
Study Completion
October 31, 2014
Last Updated
February 20, 2019
Record last verified: 2019-02