A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[Tarceva (TM)\] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)

NCT00473889

Stage IIIB or IV Non-Small Cell Lung Cancer

TERMINATED PHASE2/PHASE3

Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung

NCT00391586

Carcinoma, Non-Small-Cell Lung

TERMINATED PHASE2

A Study of Tarceva for Use in Patients With Relapsed or Refractory Metastatic Non-Small Cell Lung Cancer

NCT00283634

NSCLC

TERMINATED PHASE2

Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)

NCT00423449

Non-Small Cell Lung Cancer

COMPLETED PHASE1

Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

NCT01532089

EGFR Exon 19 Deletion Mutation EGFR NP_005219.2:p.L858R Lung Non-Squamous Non-Small Cell Carcinoma +1 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Non-Small-Cell Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk

Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

Vorinostat 200 mg twice a day for 3 days a week.

erlotinib

Intervention Type DRUG

erlotinib 150 mg once a day.

Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk

Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

Vorinostat 300 mg once a day for 3 days a week.

erlotinib

Intervention Type DRUG

erlotinib 150 mg once a day.

Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk

Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

Vorinostat 300 mg twice a day for 3 days a week.

erlotinib

Intervention Type DRUG

erlotinib 150 mg once a day.

Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk

Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

Vorinostat 400 mg once a day for 21 out of 28 days.

erlotinib

Intervention Type DRUG

erlotinib 150 mg once a day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vorinostat

Vorinostat 200 mg twice a day for 3 days a week.

Intervention Type DRUG

Vorinostat

Vorinostat 300 mg once a day for 3 days a week.

Intervention Type DRUG

Vorinostat

Vorinostat 300 mg twice a day for 3 days a week.

Intervention Type DRUG

Vorinostat

Vorinostat 400 mg once a day for 21 out of 28 days.

Intervention Type DRUG

erlotinib

erlotinib 150 mg once a day.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK0683 Zolinza® MK0683 Zolinza® MK0683 Zolinza® MK0683 Zolinza® Tarceva ®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males and females 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (NSCLC) who have failed at least one prior treatment for NSCLC.
* Patients must have proven disease by CT scan or MRI.
* Patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug.
* Patients must be 2 weeks out from radiation therapy.
* At screening the patient must have normal lab results and can not be pregnant.
* Women and men must agree to practice adequate birth control during the study.
* Patient has the ability to understand and sign the consent form.

Exclusion Criteria

* Patient had prior treatment with vorinostat or erlotinib.
* Patient has any of the following conditions: active infections including hepatitis B or C, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No