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

Phase 2TerminatedNCT00251589

Merck Sharp & Dohme LLC23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vorinostat

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study

Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study.

Time frame: Day 1 to 28 in the Phase I portion of the study

Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study

Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study.

Time frame: Day 1 to 28 in the Phase II portion of the study

Secondary Outcomes

Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)

An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable)

Time frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate

Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)

Stable disease is defined as less than a radiographic partial response, but not progressive disease

Time frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate

Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)

Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI

Time frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate

Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)

First documentation of Progressive Disease (PD) occurring \> 8 weeks on study.

Time frame: Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate

Progression-free Survival

Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded).

Time frame: Day 1 to disease progression or death