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

Lung Cancer Clinical Trial

Official title:

Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003589
• Other study ID #: EORTC-08975
• Secondary ID: EORTC-08975
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: March 5, 2012
• Start date: August 1998

Study information

• Verified date: March 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. primary completion date: July 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

• paclitaxel

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Czech Republic	University Hospital Bulovka	Krhanice
Egypt	National Cancer Institute of Egypt	Cairo
France	CHRU de Nancy - Hopitaux de Brabois	Vandoeuvre-Les-Nancy
Germany	Thoraxklinik Rohrbach	Heidelberg
Greece	Hippokration General Hospital of Athens	Athens
Italy	Ospedale degli Infermi	Biella
Netherlands	Leyenburg Ziekenhuis	's-Gravenhage (Den Haag, The Hague)
Netherlands	Groot Ziekengasthuis 's-Hertogenbosch	's-Hertogenbosch
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	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
Poland	Maritime Hospital	Gdynia
South Africa	Medical Oncology Centre of Rosebank	Johannesburg
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de Getafe	Madrid
Switzerland	Ospedale San Giovanni	Bellinzona

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Egypt,  France,  Germany,  Greece,  Italy,  Netherlands,  Poland,  South Africa,  Spain,  Switzerland, 

References & Publications (3)

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 qua — View Citation

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

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 cisplati — View Citation