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Advanced CancersPhase 1NCT01636622

Study of Vemurafenib, Carboplatin, and Paclitaxel

A Phase 1 study testing Vemurafenib, Carboplatin and Paclitaxel in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Advanced Cancers
What is being tested?
Vemurafenib, Carboplatin and Paclitaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
9 Jul 2012to 21 Apr 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I Study of the Combination of Vemurafenib With Carboplatin and Paclitaxel in Patients With Advanced Malignancy

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.

Read the detailed description

Study Groups:

If you are found to be eligible and decide to take part, you will be assigned to a study group based on when you join this study. Up to 8 groups of 3-6 participants will be enrolled in this study.

The dose of vemurafenib and the doses of carboplatin and paclitaxel you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of vemurafenib, carboplatin, and paclitaxel. Each new group will receive a higher dose level of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the combination is found. After that, 10 additional participants will be enrolled.

Study Drug Administration:

Each study cycle is 3 weeks.

You will start taking paclitaxel and carboplatin on Day 1 of Cycle 1. Paclitaxel will be given by vein over 3 hours, and carboplatin will be given by vein over 30-60 minutes. You may be given medications to reduce the risk of nausea and allergic reaction before these study drugs are given. Both paclitaxel and carboplatin will be given every 3 weeks.

You will start taking vemurafenib by mouth in the evening on Day 1 of Cycle 1. You will then take vemurafenib twice a day, every day starting with Day 2 of Cycle 1.

Study Visits:

At every study visit, you will be asked about any drugs you may be taking, how you are feeling, and if you have had any side effects.

On Day 1 of Cycle 1:

  • You will have a physical exam, including measurement of your weight and vital signs if not done in the past 8 days.
  • Your performance status will be recorded.
  • Blood (about 1 tablespoon) will be drawn for routine tests if this was not done in the past 10 days.

On Day 8 of Cycle 1:

  • You will have a physical exam, including measurement of your vital signs.
  • Your performance status will be recorded.
  • Blood (about 1 tablespoon) will be drawn for routine tests.

On Day 1 of Cycles 2 and beyond:

  • You will have a physical exam, including measurement of your weight and vital signs.
  • Your performance status will be recorded.
  • Blood (about 1 tablespoon) will be drawn for routine tests.
  • In Cycle 2 only, you will have an ECG.

After Cycle 4, if you are tolerating the study drug combination well and the study doctor agrees, you may have your Day 1 visit every other cycle.

Every 6 weeks (every 2 cycles), you will have a CT scan, MRI scan, bone scan, and/or x-ray to check the status of the disease.

Length of Study Participation:

You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest.

You will no longer be able to take the study drugs if the disease gets worse, if you start having other health problems, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over when you have completed the End-of-Study Visit.

End-of-Study Visit:

Within 4 weeks after your last dose of study drugs:

  • You will have a physical exam, including measurement of your weight and vital signs.
  • Your performance status will be recorded.
  • Blood (about 1 tablespoon) will be drawn for routine tests.
  • You will have an ECG.
  • You will have a CT scan, MRI scan, bone scan, and/or x-ray to check the status of the disease.

This is an investigational study. Vemurafenib is FDA approved and commercially available to treat advanced melanoma with mutated BRAF. Carboplatin and paclitaxel are FDA approved for certain types of cancers, including lung and ovarian cancers. Using the study drug combination to treat advanced cancer with a BRAF mutation is considered investigational.

Up to 96 participants will be enrolled in this study. All will take part at MD Anderson.

Being tested
Vemurafenib, Carboplatin, Paclitaxel
Keywords
Advanced Cancers, Advanced Malignancy, BRAF Mutation, Advanced solid tumor, Lymphoma, Vemurafenib, PLX4032, RO5185426, Carboplatin, Paraplatin, Paclitaxel, Taxol
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VemurafenibDrug

    Also called PLX4032, RO5185426

    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.

  • CarboplatinDrug

    Also called Paraplatin

    Starting dose of Carboplatin: AUC 5 by vein every 3 weeks.

  • PaclitaxelDrug

    Also called Taxol

    Starting dose of Paclitaxel: 100 mg/m2 by vein every 3 weeks.

Study groups in NCT01636622
Study groupRoleWhat they receive
Vemurafenib + Carboplatin + PaclitaxelExperimentalAll 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.
Receives: Drug: Vemurafenib; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of Vemurafenib with Carboplatin and Paclitaxel

    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.

    Measured: 6 weeks

Secondary outcomes (1)

  1. Overall Response Rate

    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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2012 (estimated)
  2. Study start9 Jul 2012
  3. Primary completion21 Apr 2020
  4. Study completion21 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01636622
Sponsor's protocol ID
2012-0394
Other IDs
NCI-2012-01221
Status last verified
Jun 2020
First submitted
6 Jul 2012
Last updated
18 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vemurafenib, Carboplatin and Paclitaxel in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of Vemurafenib with Carboplatin and Paclitaxel (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01636622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.

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