ADVANCED Phase II Trial of Weekly vs 3 Weekly Docetaxel and Cisplatin Followed by Gemcitabine in Non-small-cell Lung Cancer (NSCLC)

NCT00424853 | Completed Phase 2

• 2 other identifiers: XRP6976B_2506EudraCT # : 2004-001044-72
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, randomized phase II trial whose aim is to assess the antitumor activity of two sequential schedules of docetaxel and cisplatin followed by gemcitabine.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• overall response rate assessed by RECIST criteria.

  before, during and at the end of treatment

Secondary Outcomes (3)

• Time to progression

  from the date of randomization to the date of first documented tumor progression or relapse

• time to treatment failure

  from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administraztion of other antitumor treatment, or death for any cause

• overall survival

  time interval from the date of randomisation to the date of death

Study Arms (2)

A

EXPERIMENTAL

Drug: Docetaxel and cisplatin followed by gemcitabine

B

EXPERIMENTAL

Drug: docetaxel and cisplatin followed by gemcitabine

Interventions

docetaxel and cisplatin followed by gemcitabine DRUG

docetaxel 75 mg/m2 day 1 + cisplatin 75 mg/m2 day1 repeated every 21 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of NSCLC; Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC;
• Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System;
• Patients must have at least one measurable lesion according to RECIST criteria.
• Previous radical surgery (more 30 days before study entry) is allowed but a pathologic proof of progression of neoplastic disease must be documented;
• WHO Performance Status 0 or 1 ;
• Weight loss \< 5% within the last 3 months;
• Laboratory requirements at entry
• Blood cell counts: Absolute neutrophils \> 2.0 . 10\^9/L; Platelets \> 100 . 10\^9/L; Hemoglobin \> 10 g/dl
• Renal function: Serum creatinine \< 1 upper normal limits (UNL). In case of limit value of serum creatinine, the creatinine clearance should be \> 60 mL/min
• Hepatic functions: Serum bilirubin \< 1 x UNL; ASAT and ALAT \< 2.5 x UNL; Alkaline phosphatase \< 5 x UNL (unless accompanied by extensive bone metastases)

You may not qualify if:

• Prior systemic chemotherapy or immunotherapy ; prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment;
• Prior radiotherapy for NSCLC to measurable lesions. Prior radiotherapy (to \< 25% of the bone marrow) is allowed in non target lesions. At least 4 weeks must be elapsed since the completion of the radiotherapy and the patient must have all side effects recovered.
• Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell / non-small cell lung cancer;
• Patients with evaluable, not measurable disease only (non target lesions);
• Patients with symptomatic brain metastases or with leptomeningeal disease;
• History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years;
• History of hypersensitivity reaction to polysorbate 80;
• Pregnant or lactating women (women of childbearing potential must use adequate contraception);
• Current peripheral neuropathy NCI grade \> 2;
• Significant neurological or psychiatric disorders ;
• Participation in clinical trials with other experimental agents within 30 days of study entry;
• Other serious concomitant illness of medical conditions:
• Uncontrolled cardiovascular disease;
• History of significant neurologic or psychiatric disorders including demential or seizures;
• Active infection requiring iv antibiotics;

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Milan, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Georges Paizis, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 22, 2007
• Study Start: May 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

IT (1)