A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

NCT ID: NCT00661778

Last Updated: 2014-07-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-07-31

Brief Summary

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This study assessed 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 received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m\^2, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab + cisplatin + docetaxel

Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab was supplied as a sterile liquid in glass vials.

Cisplatin

Intervention Type DRUG

Bevacizumab was supplied as a sterile liquid in glass vials.

Docetaxel

Intervention Type DRUG

Bevacizumab was supplied as a sterile liquid in glass vials.

Interventions

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Bevacizumab

Bevacizumab was supplied as a sterile liquid in glass vials.

Intervention Type DRUG

Cisplatin

Bevacizumab was supplied as a sterile liquid in glass vials.

Intervention Type DRUG

Docetaxel

Bevacizumab was supplied as a sterile liquid in glass vials.

Intervention Type DRUG

Other Intervention Names

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Avastin Taxotere

Eligibility Criteria

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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 (\> 325 mg/day).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Palma de Mallorca, Balearic Islands, Spain

Site Status

Cadiz, Cadiz, Spain

Site Status

Castellon, Castellon, Spain

Site Status

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Alcalá de Henares, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Málaga, Malaga, Spain

Site Status

Palencia, Palencia, Spain

Site Status

Sagunto, Valencia, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valladolid, Valladolid, Spain

Site Status

Valladolid, Valladolid, Spain

Site Status

Zamora, Zamora, Spain

Site Status

Countries

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Spain

Other Identifiers

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2006-005619-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML20081

Identifier Type: -

Identifier Source: org_study_id

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