Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

NCT ID: NCT00003589

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31

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 which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Compare the overall survival between paclitaxel/cisplatin (arm I), gemcitabine/cisplatin (arm II), and paclitaxel/gemcitabine (arm III) in patients with advanced non-small cell lung cancer. II. Determine the response rate, duration of response, progression-free survival, toxicity, and quality of life of these patients randomized in these three treatment arms.

OUTLINE: This is randomized, multicenter study. Patients are stratified according to performance status (0-1 vs 2) and stage of disease (locally advanced vs metastatic). Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin IV on day 1 every 3 weeks (arm I), gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin IV on day 1 every 3 weeks (arm II), or paclitaxel IV over 3 hours on day 1 followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks (arm III). Patients receive at least 2 courses of treatment. In the absence of unacceptable toxicity and disease progression, patients may receive up to 6 courses of treatment. Quality of life is assessed before, during, and at the end of treatment, then every 6 weeks until disease progression, and then every 3 months until death. Patients are followed every 6 weeks until disease progression, then every 3 months until death.

PROJECTED ACCRUAL: A total of 450 patients (150 patients per arm) will be accrued into this study over 36 months.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced non-small cell lung cancer that is progressive within 2 months prior to study entry Stage IIIB due to malignant pleural effusion or supraclavicular lymph node involvement only Stage IV At least 1 bidimensionally or unidimensionally measurable target lesion Brain metastases or leptomeningeal disease that have been treated with radiotherapy, is stable without medications (e.g., steroids), and asymptomatic are allowed

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Prothrombin time less than 1.5 times normal Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) (no greater than 2.5 times ULN if due to liver metastases) AST or ALT less than 3 times ULN (no greater than 5 times ULN if due to liver metastases) Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled cardiac disease, sign of cardiac failure, or rhythm disturbances requiring medication No myocardial infarction in the past 3 months Neurological: No preexisting motor or sensory neurotoxicity of grade 2 or greater Other: No active uncontrolled infection Not a poor medical risk due to nonmalignant disease No secondary primary malignancy in the past 5 years (excluding melanoma, breast cancer, and hypernephroma) except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin No psychological condition that might hamper compliance in this study Not pregnant Effective contraception required of all fertile patients during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent colony stimulating factor except for secondary prophylaxis in case of infection and severe neutropenia No concurrent immunotherapy Chemotherapy: No prior chemotherapy for advanced disease, including intracavitary chemotherapy At least 1 year since prior neoadjuvant or adjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal agents (except corticosteroids for antiemetic prophylaxis) Radiotherapy: Prior radiotherapy should not include all target lesions for evaluation At least 4 weeks since prior radiotherapy Concurrent palliative radiotherapy allowed if indicator lesion is outside of radiation field Surgery: Not specified

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Egbert F. Smit, MD

Role: STUDY_CHAIR

Free University Medical Center

Locations

Algemeen Ziekenhuis Middelheim

Antwerp, , Belgium

University Hospital Bulovka

Krhanice, , Czechia

National Cancer Institute of Egypt

Cairo, , Egypt

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, , France

Thoraxklinik Rohrbach

Heidelberg, , Germany

Hippokration General Hospital of Athens

Athens, , Greece

Ospedale degli Infermi

Biella, , Italy

Leyenburg Ziekenhuis

's-Gravenhage (Den Haag, the Hague), , Netherlands

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, , Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Academisch Medisch Centrum

Amsterdam, , Netherlands

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, , Netherlands

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, , Netherlands

Arnhems Radiotherapeutisch Instituut

Arnhem, , Netherlands

Ziekenhuis de Baronie

Breda, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Ziekenhuis St Jansdal

Harderwijk, , Netherlands

Elkerliek Ziekenhuis

Helmond, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Rijnland Ziekenhuis

Leiderdorp, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

University Medical Center Nijmegen

Nijmegen, , Netherlands

University Hospital - Rotterdam Dijkzigt

Rotterdam, , Netherlands

Academisch Ziekenhuis Utrecht

Utrecht, , Netherlands

St. Maartens Gasthuis

Venlo, , Netherlands

Ziekenhuis de Heel

Zaandam, , Netherlands

Sophia Ziekehuis

Zwolle, , Netherlands

Maritime Hospital

Gdynia, , Poland

Medical Oncology Centre of Rosebank

Johannesburg, , South Africa

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario de Getafe

Madrid, , Spain

Ospedale San Giovanni

Bellinzona, , Switzerland

Countries

Belgium; Czechia; Egypt; France; Germany; Greece; Italy; Netherlands; Poland; South Africa; Spain; Switzerland

References

Giaccone G. Gemcitabine plus taxane combinations in non-small cell lung cancer. Semin Oncol. 1999 Feb;26(1 Suppl 4):19-24.

Reference Type: BACKGROUND

PMID: 10201517 (View on PubMed)

Efficace F, Bottomley A, Smit EF, Lianes P, Legrand C, Debruyne C, Schramel F, Smit HJ, Gaafar R, Biesma B, Manegold C, Coens C, Giaccone G, Van Meerbeeck J; EORTC Lung Cancer Group and Quality of Life Unit. Is a patient's self-reported health-related quality of life a prognostic factor for survival in non-small-cell lung cancer patients? A multivariate analysis of prognostic factors of EORTC study 08975. Ann Oncol. 2006 Nov;17(11):1698-704. doi: 10.1093/annonc/mdl183. Epub 2006 Sep 12.

Reference Type: RESULT

PMID: 16968876 (View on PubMed)

Smit EF, van Meerbeeck JP, Lianes P, Debruyne C, Legrand C, Schramel F, Smit H, Gaafar R, Biesma B, Manegold C, Neymark N, Giaccone G; European Organization for Research and Treatment of Cancer Lung Cancer Group. Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group--EORTC 08975. J Clin Oncol. 2003 Nov 1;21(21):3909-17. doi: 10.1200/JCO.2003.03.195.

Reference Type: RESULT

PMID: 14581415 (View on PubMed)

Other Identifiers

EORTC-08975

Identifier Type: -

Identifier Source: secondary_id

EORTC-08975

Identifier Type: -

Identifier Source: org_study_id