A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)

NCT00042315 | Terminated Phase 3

• 1 other identifier: TQD LUNG 002
• Study Type: interventional
• Target: 490
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine whether tariquidar + first-line single agent vinorelbine chemotherapy in patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly improve overall survival compared with placebo + vinorelbine. To compare the effects of tariquidar/vinorelbine with placebo/vinorelbine on tumor response, time to disease progression, performance status, symptom progression, and quality of life in patients with Stage IIIb/IV NSCLC.

Conditions

Stage IIIb Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Interventions

Chemotherapy PROCEDURE

tariquidar + vinorelbine DRUG

placebo + vinorelbine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have histologically or cytologically proven NSCLC, stage IIIb or stage IV, requiring first-line chemotherapy.
• Patients who have a WHO performance status of 2 and life expectancy of greater than 3 months.
• Patients who are 18 years of age or older and age of consent.
• Patients who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at screening, and must be practicing an adequate method of birth control.
• Patients who have neutrophils greater or equal to 1.5 x 103/µL; platelets greater or equal to 100 x 103/µL; bilirubin less or equal to 1.5 times the upper limit of normal or less or equal to 26 µmol/L (1.5 mg/dL); transaminases less or equal to 2.5 times the upper limit of normal or, for patients with known liver metastases, less or equal to 5 times the upper limit of normal; and creatinine equal or less than 141 µmol/L (1.6 mg/dL) or calculated creatinine clearance less or equal to 60 mL/min prior to study treatment.
• Patients who are able to give written informed consent and comply with the protocol.

You may not qualify if:

• Patients who are eligible for radiotherapy or surgery for curative intent.
• Patients who have had previous chemotherapy for NSCLC.
• Patients who have a WHO performance status less than 2 or greater than 2.
• Patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor cells grow upon the walls of pre-existing alveoli, from WHO histological typing of lung tumors \[66\]).
• Patients who have previous or current primary malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the cervix and basal or squamous cell skin carcinoma.
• Patients who are a poor medical risk because of other nonmalignant systemic diseases or active uncontrolled infections.
• Patients who have symptomatic brain metastases.
• Patients who have other medical or surgical conditions that would contraindicate chemotherapy.
• Patients who have received experimental therapies within the last 4 weeks.
• Patients who have know hypervitaminosis or known sensitivity to ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or vitamin E.

Sponsors & Collaborators

• QLT Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy; tariquidar; Vinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2002
• First Posted: August 1, 2002
• Study Start: June 1, 2002
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: May 23, 2012

Record last verified: 2012-05