A Study of Apomab in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00480831

Purpose

This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of Apomab combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: apomab Drug: placebo Drug: bevacizumab Drug: carboplatin Drug: paclitaxel	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Official Title:	A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without Apomab in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer

Further study details as provided by Genentech:

Primary Outcome Measures:

Progression-free survival, as determined by independent review facility [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Changes in vital signs, physical findings, and clinical laboratory results during and following Apomab administration [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response and duration of response, as determined by independent review facility [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Progression-free survival, objective response, and duration of objective response, as determined by the investigator [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Pharmacokinetic parameters [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	June 2007
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: apomab Intravenous repeating dose Drug: bevacizumab Intravenous repeating dose Drug: carboplatin Intravenous repeating dose Drug: paclitaxel Intravenous repeating dose
2: Placebo Comparator	Drug: placebo Intravenous repeating dose Drug: bevacizumab Intravenous repeating dose Drug: carboplatin Intravenous repeating dose Drug: paclitaxel Intravenous repeating dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to understand and willingness to sign a written informed consent
Histologically or cytologically confirmed NSCLC
Advanced NSCLC
Measurable disease
ECOG performance status of 0 or 1
Age ≥ 18 years
Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men

Exclusion Criteria:

Squamous cell histology
Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization
Untreated or unstable CNS metastases
Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization
Uncontrolled hypertension
History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization
Major surgical procedure within 28 days prior to randomization
Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization
Persistent history of gross hemoptysis relating to the patient's NSCLC
Known HIV infection
Known to be positive for hepatitis C or hepatitis B surface antigen
Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function
Use of anticoagulation therapy
Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization
Pregnancy (e.g., positive HCG test) or breast feeding
Known sensitivity to any of the products to be administered during the study
Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480831

Show 42 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

William Novotny, M.D.

Genentech

More Information

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	APM4074g
Study First Received:	May 30, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00480831
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

NSCLC
Cancer
Avastin

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases

Carboplatin
Bevacizumab
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 13, 2009