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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00251589
• Other study ID #: 0683-025
• Secondary ID: MK0683-0252005_0
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 7, 2005
• Last updated: February 17, 2015
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Vorinostat
Vorinostat 200 mg twice a day for 3 days a week.
• Vorinostat
Vorinostat 300 mg once a day for 3 days a week.
• Vorinostat
Vorinostat 300 mg twice a day for 3 days a week.
• Vorinostat
Vorinostat 400 mg once a day for 21 out of 28 days.
• erlotinib
erlotinib 150 mg once a day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 to 28 in the Phase I portion of the study	Yes
Primary	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.	Day 1 to 28 in the Phase II portion of the study	Yes
Secondary	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)	Every 57 days beginning with Cycle 3, or more frequently if appropriate	Yes
Secondary	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	Every 57 days beginning with Cycle 3, or more frequently if appropriate	Yes
Secondary	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	Every 57 days beginning with Cycle 3, or more frequently if appropriate	Yes
Secondary	Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)	First documentation of Progressive Disease (PD) occurring > 8 weeks on study.	Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate	Yes
Secondary	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).	Day 1 to disease progression or death	Yes