A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
This study has been terminated.
Information provided by (Responsible Party):
First received: July 26, 2002
Last updated: May 22, 2012
Last verified: May 2012
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.
Stage IIIb Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: tariquidar + vinorelbine
Drug: placebo + vinorelbine
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2003 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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 ).
- 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.
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History of Changes
|Other Study ID Numbers:
TQD LUNG 002
|Study First Received:
||July 26, 2002
||May 22, 2012
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2017
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action