Regimen for the Treatment of Cachexia in Subjects With NSCLC

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-09-30

Brief Summary

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Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized.

To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.

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Detailed Description

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The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen

This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.

Conditions

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Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A, control group

Supportive care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B, Low Dose VT-122

VT-122 (dose of etodolac: 400 mg/day) + supportive care

Group Type ACTIVE_COMPARATOR

VT-122 low dose

Intervention Type DRUG

VT-122 low dose, dose escalated

Group C, High Dose VT-122

VT-122 (dose of etodolac: 800 mg/day) + supportive care

Group Type ACTIVE_COMPARATOR

VT-122 high dose

Intervention Type DRUG

VT-122 high dose, dose escalated

Interventions

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VT-122 low dose

VT-122 low dose, dose escalated

Intervention Type DRUG

VT-122 high dose

VT-122 high dose, dose escalated

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with NSCLC
* Demonstrating average weight loss of 5% within 2 months prior to enrollment
* Heart rate of 72 bpm or greater
* Negative pregnancy test (female patients of child bearing age)
* Able to give informed consent
* Able to be administered medication
* Able to take food and defined nutritional support
* Have not been on beta-blockers for a minimum of 1 week prior to administration of the medication screening dose
* Have not undergone surgery for at least 2 weeks prior to entry into trial
* Have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and experimental therapy for a minimum of two weeks prior to medication screening dose and during their participation in this trial
* An expected survival for a minimum of 12 weeks

Exclusion Criteria

* Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers
* Blood pressure less than 100/65
* Weight loss of 15% within 2 months prior to recruitment
* Hypersensitivity reaction to the active components in VT-122
* History of myocardial infraction within the past 3 months
* Congestive heart failure (as determined by symptoms and ECG)
* A-V block of second or third degree
* Unstable angina
* Uncontrolled diabetes
* Unable to be assessed for grip strength
* A positive pregnancy test
* Chronic infection or sepsis
* History of bleeding disorders
* Patients with peripheral edema
* Patients on digoxin or other chronotropic drugs
* Patients with evidence of severe dehydration
* Patients with evidence of ascites

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No