A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
This study has been terminated.
(Primary (safety) endpoint reached)
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00404703
First received: November 28, 2006
Last updated: August 26, 2008
Last verified: August 2008
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Purpose
This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: bevacizumab [Avastin] Drug: Platinum-based chemotherapy |
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 of the Safety of First-Line Treatment With Avastin in Combination With Cisplatin-Gemcitabine or Carboplatin-Paclitaxel in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Rate of grade >=3 Avastin-related pulmonary hemorrhage [ Time Frame: After a maximum of 12 months treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall response, duration of response, progression-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory parameters, coagulation parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Estimated Study Completion Date: | March 2008 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
15mg iv on day 1 of each 3 week cycle
Drug: Platinum-based chemotherapy
As prescribed
|
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;
- documented squamous non-small cell lung cancer;
- stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease;
- suitable for platinum-based treatment as first line chemotherapy.
Exclusion Criteria:
- prior systemic anti-tumor therapy;
- prior radiotherapy for treatment of patient's current stage of disease;
- other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
- major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404703
Locations
| Australia | |
| Tugun, Australia | |
| Wollongong, Australia | |
| Belgium | |
| Liege, Belgium | |
| Czech Republic | |
| Ostrava, Czech Republic | |
| Usti nad Labem, Czech Republic | |
| France | |
| Bobigny, France | |
| Marseille, France | |
| Nantes, France | |
| Hungary | |
| Szekesfehervar, Hungary | |
| Szombathely, Hungary | |
| Israel | |
| Kfar Saba, Israel | |
| Ramat Gan, Israel | |
| Poland | |
| Lublin, Poland | |
| Poznan, Poland | |
| Szczecin, Poland | |
| Warszawa, Poland | |
| Russian Federation | |
| Balashikha, Russian Federation | |
| Moscow, Russian Federation | |
| St. Petersburg, Russian Federation | |
| Spain | |
| Madrid, Spain | |
| Sevilla, Spain | |
| Taiwan | |
| Kueishan, Taiwan | |
| Taichung, Taiwan | |
| Taipei, Taiwan | |
| Taoyuan, Taiwan | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00404703 History of Changes |
| Other Study ID Numbers: | BO19734 |
| Study First Received: | November 28, 2006 |
| Last Updated: | August 26, 2008 |
| Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
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 |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013