Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT00536107 | Terminated Phase 4 Results

• 1 other identifier: D7913C00046
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open- label, parallel group, phase IV, multicentre study. The total number of patients expected to be recruited is 40. These randomized patients will have a histologically or cytologically confirmed adenocarcinoma histology of locally advanced or metastatic NSCLC. Patients will be recruited by investigational sites that have expertise in treating patients with non-small cell lung cancer. The study will compare gefitinib monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks with a primary endpoint of safety and tolerability. The target population will be patients who have received one prior platinum-based chemotherapy and are now considered suitable candidates for further chemotherapy with docetaxel. At study entry, patients will be randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). Patients may continue to receive treatment with either gefitinib or docetaxel until disease progression, unacceptable toxicity or the occurrence of any of the other specific criteria. An independent committee will be appointed to perform a blinded review of all patient scans. Any assessments/visits after screening should be performed within a window of plus or minus 3 working days of the scheduled visit date. If selected screening evaluations are done within 7 days of Day 1, Cycle 1 of treatment, and are acceptable for study entry, they do not have to be repeated on Day 1 unless the investigator believes that they are likely to have significantly changed. Any patient who discontinues from study treatment without radiological evidence of disease progression (except for withdrawal of consent by patient) should continue to have objective tumor assessments every 6 weeks in order to collect information on progression of disease

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small Cell Lung Cancer; Locally Advanced or Metastatic NSCL Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Adverse Event (AE)

  From time consent was given to 28 days after last dose of study drug.

• Number of Patients With Serious Adverse Events (SAEs)

  From time consent was given to 28 days after last dose

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

docetaxel

Procedure: CT or MRI; Drug: Docetaxel

Gefitinib

EXPERIMENTAL

Gefitinib (IRESSA)

Drug: Gefitinib; Procedure: CT or MRI

Interventions

Gefitinib DRUG

250 mg oral

Also known as: IRESSA

Gefitinib

CT or MRI PROCEDURE

performed at screening and every 6 weeks

Docetaxel; Gefitinib

Docetaxel DRUG

60mg/m2 intravenous infusion

Also known as: Paxel

Docetaxel

Eligibility Criteria

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

You may qualify if:

• Locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC, not amenable to curative surgery or radiotherapy
• Treatment with one prior chemotherapy regimen, which must have been platinum based\* \*Patients must have demonstrated radiological or clinical progression since completion of previous chemotherapy regimen.
• Adequate hepatic function, defined as BOTH a bilirubin \< upper limit of reference range (ULRR) AND an "Eligible" combination of transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) and alkaline phosphatase (ALP) below: Not Eligible: AST or ALT \> 5xULRR, 1.5xULRR \< AST or ALT \< 5xULRR and ALP\> ULRR, 1xULRR \< AST or ALT \< 1.5xULRR and ALP\> 2.5xULRR, AST or ALT \<= ULRR and ALP\> 5xULRR For more information please refer to TAXOTERE® (docetaxel) prescribing information

You may not qualify if:

• Prior therapy with gefitinib or other EGFR TK inhibitors (HER-1 receptor inhibitors/small molecule or monoclonal antibody therapy)
• Prior docetaxel treatment for NSCLC
• Patients with pre-existing peripheral neuropathy ³ grade 2 (NCI CTCAE criteria)
• Past medical history of interstitial lung disease, drug induced interstitial disease, radiation pneumonitis that required steroid treatment or any evidence of clinically active interstitial lung disease

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; Magnetic Resonance Spectroscopy; Docetaxel

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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

This study was terminated early because the purpose of this study had been fulfilled by other supporting data, and due to small number of patients enrolled (14 patients).

Results Point of Contact

• Title: Sharon Chang
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Han-Pin Kuo, MD

  Director of Chest Department, Chang Gung Memorial Hospital, Linkou

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 27, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 1, 2013
• Results First Posted: October 1, 2013

Record last verified: 2013-08

Locations

TW (1)