Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Natural history/Epidemiology, Treatment	Closed	18 to 75	Other	ITA-INTN-DISTAL EU-20103, NCT00022022

Objectives

1. Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy.
2. Compare the toxicity of these regimens in these patients.
3. Compare the response rate, time to progression, and survival of these patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
  • Metastatic supraclavicular lymphadenopathy or malignant pleural effusion
  • Progressive disease
  • Must have received prior chemotherapy
• No symptomatic brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• No prior docetaxel
• At least 3 weeks since other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy allowed
• No concurrent radiotherapy

Surgery:

• Prior radical surgery for NSCLC allowed
• Concurrent palliative surgery allowed

Patient Characteristics:

Age:

• 18 to 75

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 1.25 times ULN

Renal:

• Creatinine no greater than 1.25 times ULN

Cardiovascular:

• No prior or concurrent cardiovascular disease that would preclude study

Pulmonary:

• See Disease Characteristics
• No prior or concurrent pulmonary disease that would preclude study

Other:

• No prior or other concurrent illness or medical condition that would preclude study
• No other prior malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer

Expected Enrollment

A total of 200 patients will be accrued for this study.

Outcomes

Quality of life
Toxicity
Response rate
Time to progression
Survival

Outline

This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a maximum of 6 courses.
• Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8 weeks for a maximum of 2 courses.

Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II.

Gridelli C, Gallo C, Di Maio M, et al.: A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study. Br J Cancer 91 (12): 1996-2004, 2004.[PUBMED Abstract]

Di Maio M, Perrone F, Chiodini P, et al.: Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 25 (11): 1377-82, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Istituto Nazionale per lo Studio e la Cura dei Tumori

Cesare Gridelli, MD, Protocol chair		Ph: 39-081-590-3637 Email: cgridelli@libero.it

Registry Information
Official Title		Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
Trial Start Date		2000-12-22
Registered in ClinicalTrials.gov		NCT00022022
Date Submitted to PDQ		2001-05-02
Information Last Verified		2006-04-12

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