A Study of Pemetrexed, Carboplatin and Bevacizumab in Patients With Nonsquamous Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00762034

Purpose

This study will compare overall survival in patients with Stage IIIB or IV nonsquamous non-small cell lung cancer.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Drug: Pemetrexed Drug: Paclitaxel Drug: Carboplatin Biological: Bevacizumab	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized, Open-Label, Phase 3 Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab Versus Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Overall survival [ Time Frame: Baseline to date of death from any cause ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall response rate [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]
Disease control rate [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]
Progression free survival time [ Time Frame: Baseline to measured progressive disease or date of death from any cause ] [ Designated as safety issue: Yes ]
Time to progressive disease [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]
Safety and toxicity profile of study treatments [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
Compare hospitalizations between the treatment arms [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
Compare transfusions between treatment arms. [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
Compare concomitant medication use between treatment arms. [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
Patient reported outcomes as assessed by the Functional Assessment of Cancer Therapy - Lung/Neurotoxicity. [ Time Frame: Baseline and every cycle ] [ Designated as safety issue: Yes ]
Pharmacokinetics (PK) of carboplatin and bevacizumab in the two treatment arms, and PK of pemetrexed in the experimental arm. [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]
Translational research to assess biomarkers relevant to study therapy and disease state. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Translational research to assess relation between biomarkers and clinical outcome. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	December 2008
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Pemetrexed, carboplatin and bevacizumab followed by pemetrexed and bevacizumab	Drug: Pemetrexed Induction therapy 500mg/m2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Other Names: Alimta LY231514 Drug: Pemetrexed Maintenance therapy 500mg/m2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation Other Names: Alimta LY231514 Drug: Carboplatin Induction therapy AUC 6 IV every 21 days for up to 4 cycles of 21 days Biological: Bevacizumab Induction therapy 15mg/kg IV every 21 days for up to 4 cycles of 21 days Biological: Bevacizumab Maintenance therapy 15mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Active Comparator: B Paclitaxel, carboplatin and bevacizumab followed by bevacizumab	Drug: Paclitaxel Induction therapy 200mg/m2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Drug: Carboplatin Induction therapy AUC 6 IV every 21 days for up to 4 cycles of 21 days Biological: Bevacizumab Induction therapy 15mg/kg IV every 21 days for up to 4 cycles of 21 days Biological: Bevacizumab Maintenance therapy 15mg/kg IV every 21 days until progressive disease or treatment discontinuation.

Arms

Assigned Interventions

Experimental: A

Pemetrexed, carboplatin and bevacizumab followed by pemetrexed and bevacizumab

Drug: Pemetrexed

Induction therapy 500mg/m2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days

Other Names:

Alimta
LY231514

Drug: Pemetrexed

Maintenance therapy 500mg/m2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation

Other Names:

Alimta
LY231514

Drug: Carboplatin

Induction therapy AUC 6 IV every 21 days for up to 4 cycles of 21 days

Biological: Bevacizumab

Induction therapy 15mg/kg IV every 21 days for up to 4 cycles of 21 days

Biological: Bevacizumab

Maintenance therapy 15mg/kg IV every 21 days until progressive disease or treatment discontinuation.

Active Comparator: B

Paclitaxel, carboplatin and bevacizumab followed by bevacizumab

Drug: Paclitaxel

Induction therapy 200mg/m2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days

Drug: Carboplatin

Induction therapy AUC 6 IV every 21 days for up to 4 cycles of 21 days

Biological: Bevacizumab

Induction therapy 15mg/kg IV every 21 days for up to 4 cycles of 21 days

Biological: Bevacizumab

Maintenance therapy 15mg/kg IV every 21 days until progressive disease or treatment discontinuation.

Eligibility

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

Criteria

Inclusion Criteria:

You must sign an informed consent document for clinical research.
You must have Stage IIIB or Stage IV nonsquamous non-small cell lung cancer.
You must not have received any prior treatment for your disease.
Prior radiation therapy is allowed to < 25% of the bone marrow; however, prior radiation to the whole pelvis is not allowed. If you have had radiation therapy to the chest, you are not eligible to participate.
You must be at least 18 years of age or older.
You must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) or disease can be evaluated on CT scan.
Your test results assessing the function of blood forming tissue, kidneys and liver must be satisfactory.
Women must be sterile, postmenopausal or on contraception and men must be sterile (e.g. post-vasectomy) or on contraception.

Exclusion Criteria:

You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
You cannot have NSCLC of predominantly squamous cell histology.
You cannot have known central nervous system (CNS) disease, other than stable, treated brain metastasis.
You cannot have undergone a surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days of starting the study treatment, or have an anticipated need for major surgery during the study.
You cannot have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
You are currently receiving ongoing treatment with full-dose warfarin or equivalent.
You cannot have significant vascular disease, serious cardiac conditions (such as heart attack), stroke or transient ischemic attack within 6 months of the trial.
You cannot have evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
You cannot have inadequately controlled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.
You cannot have a serious, nonhealing wound, active ulcer, or untreated bone fracture.
You cannot have another form of cancer, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.
You cannot have received an investigational treatment within 30 days prior to the trial.
You cannot have previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab.
You cannot be pregnant or breast-feeding.
You cannot have a known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.
You cannot have a history of hemoptysis (coughing blood) within 3 months prior to the trial.
You are unable to stop taking aspirin more than 1.3 grams per day or other nonsteroidal anti-inflammatory drugs (NSAIDs).
You are unable or unwilling to take folic acid or vitamin B12 supplementation.
You are unable to take corticosteroids.
You have any other on-going illnesses including active infections that may not allow you to adhere to the requirements of the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762034

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)

1-317-615-4559

Show 130 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMC - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Patel JD, Bonomi P, Socinski MA, Govindan R, Hong S, Obasaju C, Pennella EJ, Girvan AC, Guba SC. Treatment rationale and study design for the pointbreak study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2009 Jul;10(4):252-6.

Responsible Party:	Chief Medical Officer, Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00762034 History of Changes
Other Study ID Numbers:	9707, H3E-MC-JMHD
Study First Received:	September 26, 2008
Last Updated:	September 16, 2011
Health Authority:	United States: Food and Drug Administration

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
Pemetrexed
Bevacizumab
Carboplatin
Paclitaxel
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012