A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)

Study Overview
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Brief Summary
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This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid.

Official Title
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A Phase II Clinical Study of Oral Suberoylanilide Hydroxamic Acid in Patients With Relapsed or Refractory Breast, Colorectal, and Non-small Cell Lung Cancer.

Conditions
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Breast Cancer, Colorectal Cancer, Non-small-cell Lung Carcinoma

Intervention / Treatment
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* Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)
* Drug: Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen. Has a measurable, positron emission tomography (PET) assessable lesion Adequate blood, liver, bone marrow and kidney functions Has not received any chemotherapy for at least 4 weeks prior to entry in this study Agrees to take adequate measures to prevent pregnancy. Exclusion Criteria: Patient has had prior treatment with histone deacetylase (HDAC) inhibitor. Patient has had treatment with investigational agents within the last 30 days. Patient has active infection or had intravenous (IV) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs. Patient has HIV, hepatitis B or hepatitis C infection. Patient is pregnant or lactating. Patient has allergy to any component of the study drug.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)|nan|
|Drug: Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron emission tomography (PET) as an earlier indicator of the response to SAHA as assessed by RECIST criteria. To evaluate the safety and tolerability of SAHA for 14 days every 21 days. |  |  |