A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-Small Cell Lung Cancer.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661778
First received: April 17, 2008
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This study will assess the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients will receive Avastin 15mg/kg i.v., docetaxel 75mg/kg and cisplatin 75mg/m2 on day 1 of each 3 week cycle, for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: bevacizumab [Avastin] Drug: docetaxel Drug: cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of survival; response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | July 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle
Drug: docetaxel
75mg/kg iv on day 1 of each 3 week cycle
Drug: cisplatin
75mg/m2 iv on day 1 of each 3 week cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- stage IIIb or IV non-small cell lung cancer;
- chemotherapy-naive.
Exclusion Criteria:
- previous treatment for non-small cell lung cancer;
- previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer;
- major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to start of study;
- recent or current chronic treatment with aspirin (>325mg/day).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661778
Locations
| Spain | |
| Cádiz, Cadiz, Spain, 11009 | |
| San Sebastian, Guipuzcoa, Spain, 20080 | |
| Palma de Mallorca, Islas Baleares, Spain, 07198 | |
| Alcala de Henares, Madrid, Spain, 28805 | |
| Sagunto, Valencia, Spain, 46520 | |
| Castellon, Spain, 12002 | |
| Madrid, Spain, 28935 | |
| Madrid, Spain, 28036 | |
| Malaga, Spain, 29010 | |
| Palencia, Spain, 34005 | |
| Valencia, Spain, 46017 | |
| Valladolid, Spain, 47010 | |
| Valladolid, Spain, 47005 | |
| Zamora, Spain, 49021 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00661778 History of Changes |
| Other Study ID Numbers: | ML20081, 2006-005619-88 |
| Study First Received: | April 17, 2008 |
| Last Updated: | May 23, 2013 |
| Health Authority: | Spain: Ministry of Health |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel |
Bevacizumab Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013