A Phase I/II Clinical Trial of an Experimental Cancer Drug in Combination With an FDA Approved Cancer Drug for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Non-Small-Cell Lung
Intervention: vorinostat (Drug); erlotinib (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To determine the maximum tolerated dose (MTD) of vorinostat in combination with erlotinib when administered to patients with relapsed/refractory non-small-cell lung cancer (NSCLC) in two different dose escalation regimens.
Secondary outcome: To assess the safety and tolerability of these regimens. To evaluate activity, as assessed by objective response rate and progression rate at 8 weeks, in patients treated with vorinostat and erlotinib in combination.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: November 2005
Ending date: October 2007
Last updated: December 13, 2007
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