Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

NCT00004209 | Unknown Phase 3

• 3 other identifiers: ICRF-95.240CDR0000067457EU-99017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether three courses of combination chemotherapy are more effective than six courses of combination chemotherapy for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of three courses of combination chemotherapy with that of six courses of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

cisplatin DRUG

mitomycin C DRUG

vinblastine sulfate DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven stage IIIB or IV non-small cell lung cancer that is not eligible for surgery or radical radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod-WHO 0-2 Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 10 g/dL WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Liver function tests no greater than 2 times normal (unless due to metastatic disease) Renal: Creatinine clearance greater than 60 mL/min EDTA clearance greater than 60 mL/min Other: No serious, uncontrolled, concurrent medical illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior conventional chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (2)

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Mitomycin; Vinblastine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indolizidines; Indolizines

Study Officials

• Ian E. Smith, MD

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2000
• First Posted: September 16, 2004
• Study Start: May 1, 1998
• Last Updated: August 7, 2013

Record last verified: 2007-06

Locations

GB (2)