CompletedPhase 2NCT00064350

Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer

RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.

Checked against the public recordLast updated Jun 29, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations141
SponsorEastern Cooperative Oncology Group
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Eastern Cooperative Oncology Group
Interventions being studied
Drug: Sorafenib; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) * Disease must have progressed after at least 2 prior chemotherapy regimens for NSCLC * Patients must have measurable or nonmeasurable disease * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 3 times ULN (5 times ULN in patients with liver disease) * Creatinine less than 1.5 times ULN or calculated creatinine clearance greater than 50 mL/min * More than 3 weeks since prior chemotherapy, radiotherapy, immunotherapy or other investigational drug use * Recovered from all prior therapy * Fertile patients must use effective contraception * Age \>= 18 * ECOG performance status of 0-1 Exclusion Criteria: * Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable and off therapy for at least 2 months * Active second malignancy * Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms of coronary heart disease * Prior radiotherapy to the only site of measurable or evaluable disease unless there is evidence of disease progression in that site * Prior exposure to a ras pathway inhibitor (e.g., farnesyl transferase inhibitor) * Concurrent medications known to be metabolized by the liver with a narrow therapeutic index, including the following: * Ketoconazole * Itraconazole * Quinidine * Digoxin * Cyclosporine * Ritonavir * Grapefruit products * Carbamazepine * Phenytoin * Phenobarbital * Pregnant or nursing * Clinically serious active infection * Medical conditions, substance abuse or psychological/social situation that would preclude study participation

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Stanford Comprehensive Cancer Center - StanfordStanford, California
  • Aurora Presbyterian HospitalAurora, Colorado
  • Boulder Community HospitalBoulder, Colorado
  • Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado
  • Porter Adventist HospitalDenver, Colorado
  • Presbyterian - St. Luke's Medical CenterDenver, Colorado
  • St. Joseph HospitalDenver, Colorado
  • Rose Medical CenterDenver, Colorado
  • CCOP - Colorado Cancer Research ProgramDenver, Colorado
  • Swedish Medical CenterEnglewood, Colorado
  • Front Range Cancer SpecialistsFort Collins, Colorado
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 29, 2023. Always confirm current availability with the study team.

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