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Study of Vemurafenib, Carboplatin, and Paclitaxel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01636622
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Advanced Cancers Drug: Vemurafenib Drug: Carboplatin Drug: Paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of the Combination of Vemurafenib With Carboplatin and Paclitaxel in Patients With Advanced Malignancy
Actual Study Start Date : July 9, 2012
Actual Primary Completion Date : April 21, 2020
Actual Study Completion Date : April 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • PLX4032
  • RO5185426

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




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Vemurafenib with Carboplatin and Paclitaxel [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be age >/= 12 years.
  2. 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.
  3. Patient with QTc interval must be less than 500 msec.
  4. 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.
  5. Patients must have evaluable disease for response.
  6. Patient must have an ECOG performance status of 0 to 2.
  7. 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) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome); 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
  8. 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
  9. 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).
  10. Patient must be willing and able to sign the informed consent form.

Exclusion Criteria:

  1. 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.
  2. Patients with an inability to swallow tablets or capsules
  3. Patients with leptomeningeal disease;
  4. Patients who are pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636622


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Filip Janku, MD, PHD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01636622    
Other Study ID Numbers: 2012-0394
NCI-2012-01221 ( Registry Identifier: NCI CTRP )
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Advanced Malignancy
BRAF Mutation
Advanced solid tumor
Lymphoma
Vemurafenib
PLX4032
RO5185426
Carboplatin
Paraplatin
Paclitaxel
Taxol
Additional relevant MeSH terms:
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Paclitaxel
Carboplatin
Vemurafenib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors