Study of Vemurafenib, Carboplatin, and Paclitaxel
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The goal of this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with carboplatin and paclitaxel patients with advanced cancer. The safety of the study drug combination will also be studied.
Vemurafenib is designed to block a protein (called mutated BRAF) that is only found in moles (spots) of the skin and certain types of cancer cells. This drug may slow the growth of or kill these cells.
Carboplatin is designed to slow the growth of cancer cells by stopping them from making new DNA (the genetic material of cells).
Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing into new cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers |
Drug: Vemurafenib Drug: Carboplatin Drug: Paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of the Combination of Vemurafenib With Carboplatin and Paclitaxel in Patients With Advanced Malignancy |
- Maximum Tolerated Dose (MTD) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of the dose limiting toxicity (DLT) is < 33%. If at any time more than or equal to one third of participants at a dose level experience DLT, that dose is considered to be above the MTD.
- Overall Response Rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]RECIST version 1.1 used to evaluate the response rate. Response rate calculated using point estimate, together with 95% confidence interval (CI). Overall response rate at end of study also calculated. Overall survival (OS) and time to progression (TTP) also calculated using Kaplan-Meier method. Kaplan-Meier method used to estimate progression free survival (PFS) time. PFS defined as time interval between start of treatment to date of disease progression, or death.
| Estimated Enrollment: | 96 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vemurafenib + Carboplatin + Paclitaxel
All 3 study drugs will start on day 1 of cycle 1. Cycle defined as 3 weeks. On day 1, paclitaxel and carboplatin will be administered first, and the vemurafenib administration will start in the evening that day. Starting dose of Paclitaxel: 100 mg/m2 by vein every 3 weeks. Starting dose of Carboplatin: AUC 5 by vein every 3 weeks. Starting dose of Vemurafenib: 480 mg by mouth mouth in the evening on Day 1 of Cycle 1, then twice a day starting on Day 2 for a 3 week cycle. |
Drug: Vemurafenib
Starting dose of Vemurafenib: 480 mg by mouth mouth in the evening on Day 1 of Cycle 1, then twice a day starting on Day 2 for a 3 week cycle.
Other Names:
Drug: Carboplatin
Starting dose of Carboplatin: AUC 5 by vein every 3 weeks.
Other Name: Paraplatin
Drug: Paclitaxel
Starting dose of Paclitaxel: 100 mg/m2 by vein every 3 weeks.
Other Name: Taxol
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must be age >/= 12 years.
- Patient must have histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma harboring a BRAF mutation, for which no standard therapy is available, is resistant/refractory to standard therapy, has relapsed after standard therapy, or has no standard therapy that improves survival by at least three months.
- Patient with QTc interval must be less than 500 msec.
- Patient must have completed any prior cytotoxic chemotherapy or radiation therapy at least 21 days prior to starting the study drug(s), except selective RAF inhibitors (vemurafenib, dabrafenib or LGX818). There is no washout period for prior selective RAF inhibitors. Patients must be at least 5 half-lives or 3 weeks, whichever is shorter, from their previous targeted or biologic therapy. Local palliative radiation therapy that is not delivered to all target lesions is allowed immediately before or during treatment.
- Patients must have evaluable disease for response.
- Patient must have an ECOG performance status of 0 to 2.
- Patient must have adequate liver and renal function as documented by the following laboratory test results within 14 days prior to starting therapy: total bilirubin less than or equal to 2 x upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) less than or equal to 2.5 X ULN or less than or equal to 5 X ULN if liver metastasis is present; serum creatinine less than or equal to 2 X ULN
- Patient must have adequate bone marrow function as documented by the following laboratory test results within 14 days prior to starting therapy: platelets greater than 75,000/mm^3;absolute neutrophil count (ANC) greater than 1000/mm^3; hemoglobin greater than 8.0 g/dL
- Patient (man or woman) must agree to practice effective contraception during the entire study period, unless documentation of infertility exists, and for at least 4 weeks after the last dose of the study drug(s).
- Patient must be willing and able to sign the informed consent form.
Exclusion Criteria:
- Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to: active or uncontrolled infection; or unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled cardiac arrhythmia.
- Patients with an inability to swallow tablets or capsules
- Patients with leptomeningeal disease;
- Patients who are pregnant or breastfeeding
Contacts and Locations| Contact: Gerald Falchook, MD, MS | 713-563-1930 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Gerald Falchook, MD,MS | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01636622 History of Changes |
| Other Study ID Numbers: | 2012-0394 |
| Study First Received: | July 6, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Vemurafenib PLX4032 Advanced Cancers Advanced Malignancy BRAF Mutation Advanced solid tumor |
Lymphoma RO5185426 Carboplatin Paraplatin Paclitaxel Taxol |
Additional relevant MeSH terms:
|
Neoplasms Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013