Clinical trial NCT00022022: Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Official title: Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Detailed description: OBJECTIVES:

* 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.
* Compare the toxicity of these regimens in these patients.
* Compare the response rate, time to progression, and survival of these patients treated with these regimens.

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.

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

Eligibility 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

PATIENT CHARACTERISTICS:

Age:

* 18 to 75

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* 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

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

Primary outcomes:
measure: Quality of life
measure: Toxicity
measure: Response rate
measure: Time to progression
measure: Survival
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Istituto Di Ricovero E Cura A Carattere Scientifico
city: Benevento
country: Italy
facility: Azienda Ospedaliena G. Rummo
city: Campobasso
country: Italy
facility: Ospedale Cardarelli - Campobasso
city: Cosenza
country: Italy
facility: Ospedale Civile Cosenza
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Milan
country: Italy
facility: Ospedale San Giuseppe
city: Milan
country: Italy
facility: Ospedale Luigi Sacco
city: Naples
country: Italy
facility: Federico II University Medical School
city: Naples
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Naples
country: Italy
facility: Ospedale Vincenzo Monaldi
city: Naples
country: Italy
facility: Seconda Universita di Napoli
city: Noale
country: Italy
facility: Ospedale Civile P.F. Calvi
city: Palermo
country: Italy
facility: Azienda Ospedaliera Policlinico Paolo Giaccone
city: Palermo
country: Italy
facility: Ospedale La Maddalena - Palermo
city: Potenza
country: Italy
facility: Ospedale San Carlo
city: Salerno
country: Italy
facility: Ospedale da Procida
Study officials:
affiliation: Istituto Nazionale per lo Studio e la Cura dei Tumori
name: Cesare Gridelli, MD
role: STUDY_CHAIR
References:
citation: Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. 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. 2007 Apr 10;25(11):1377-82. doi: 10.1200/JCO.2006.09.8251.
citation: Gridelli C, Gallo C, Di Maio M, Barletta E, Illiano A, Maione P, Salvagni S, Piantedosi FV, Palazzolo G, Caffo O, Ceribelli A, Falcone A, Mazzanti P, Brancaccio L, Capuano MA, Isa L, Barbera S, Perrone F. 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. 2004 Dec 13;91(12):1996-2004. doi: 10.1038/sj.bjc.6602241.