Clinical trial NCT00251589: A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)
Official title: A Phase I/II Clinical Trial of Oral Vorinostat (MK0683) in Combination With Erlotinib in Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Relapsed Non-Small-Cell Lung Cancer
Refractory Non-Small-Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-11-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study
timeFrame: Day 1 to 28 in the Phase I portion of the study
measure: Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study
timeFrame: Day 1 to 28 in the Phase II portion of the study
Secondary outcomes:
measure: Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)
timeFrame: Every 57 days beginning with Cycle 3, or more frequently if appropriate
measure: Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)
timeFrame: Every 57 days beginning with Cycle 3, or more frequently if appropriate
measure: Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)
timeFrame: Every 57 days beginning with Cycle 3, or more frequently if appropriate
measure: Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)
timeFrame: Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate
measure: Progression-free Survival
timeFrame: Day 1 to disease progression or death
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: