A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer
This study has been terminated.
(This trial is being closed based on lack of substantive efficacy, slow accrual and overall tolerance in patients treated to date.)
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00251589
First received: November 7, 2005
Last updated: March 9, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: Vorinostat Drug: erlotinib |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Dose Limiting Toxicity (DLT) Occurring 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 ] [ Designated as safety issue: Yes ]
- Dose Limiting Toxicity Occurring 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST) [ Time Frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate ] [ Designated as safety issue: Yes ]
- Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST) [ Time Frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate ] [ Designated as safety issue: Yes ]
- Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST) [ Time Frame: Every 57 days beginning with Cycle 3, or more frequently if appropriate ] [ Designated as safety issue: Yes ]
- Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST) [ Time Frame: Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate ] [ Designated as safety issue: Yes ]
- Progression-Free Survival [ Time Frame: Day 1 to disease progression or death ] [ Designated as safety issue: Yes ]
| Enrollment: | 23 |
| Study Start Date: | November 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort B, Dose Level 1 |
Drug: Vorinostat
Vorinostat 200 mg twice a day for 3 days a week.
Other Names:
Drug: erlotinib
erlotinib 150 mg once a day.
Other Name: Tarceva ®
|
| Experimental: Cohort A, Dose Level 1 (amended) |
Drug: Vorinostat
Vorinostat 300 mg once a day for 3 days a week.
Other Names:
Drug: erlotinib
erlotinib 150 mg once a day.
Other Name: Tarceva ®
|
| Experimental: Cohort B, Dose Level 2 |
Drug: Vorinostat
Vorinostat 300 mg twice a day for 3 days a week.
Other Names:
Drug: erlotinib
erlotinib 150 mg once a day.
Other Name: Tarceva ®
|
| Experimental: Cohort A, Dose Level 1 (original) |
Drug: Vorinostat
Vorinostat 400 mg once a day for 21 out of 28 days.
Other Names:
Drug: erlotinib
erlotinib 150 mg once a day.
Other Name: Tarceva ®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00251589 History of Changes |
| Other Study ID Numbers: | 2005_080, MK0683-025 |
| Study First Received: | November 7, 2005 |
| Results First Received: | October 27, 2008 |
| Last Updated: | March 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Relapsed Non-Small-Cell Lung Cancer Refractory Non-Small-Cell Lung Cancer |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Vorinostat Erlotinib Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013