Study of Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by (Responsible Party):	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00948675

Purpose

The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in patients with Stage IIIB or IV nonsquamous non-small cell lung cancer.

Condition	Intervention	Phase
Advanced Non-Small Cell Lung Cancer	Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel Biological: Bevacizumab	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Study of Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed vs Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced NCSLC of Nonsquamous Histology

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:

Progression free survival without grade 4 toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. [ Time Frame: Baseline to measured progressive disease or treatment discontinuation, assessed at 3 years. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: Baseline to measured progressive disease, assessed at 3 years. ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Baseline to date of death from any cause, assessed at 3 years. ] [ Designated as safety issue: No ]
Overall Tumor Response rate [ Time Frame: Baseline to date of confirmed response, assessed at every other 21 day cycle. ] [ Designated as safety issue: No ]
Disease control rates defined as complete response, partial response, and stable disease [ Time Frame: Baseline to date of confirmed response, assessed at every other 21 day cycle. ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	September 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pemetrexed + Carboplatin + Pemetrexed Pemetrexed and Carboplatin followed by Pemetrexed	Drug: Pemetrexed Induction therapy: 500mg/m2 given intravenously every 21 days X 4 cycles. Maintenance therapy: 500 mg/m2 given intravenously every 21 days until disease progression or treatment discontinuation. Other Name: ALIMTA, LY231514 Drug: Carboplatin Induction Therapy (every 21 days X 4 cycles): Area Under the Curve (AUC)6 intravenously infused over 30 minutes.
Active Comparator: Paclitaxel + Carboplatin + Bevacizumab Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab	Drug: Carboplatin Induction Therapy (every 21 days X 4 cycles): Area Under the Curve (AUC)6 intravenously infused over 30 minutes. Drug: Paclitaxel Induction Therapy(every 21 days X 4 cycles): 200 mg/m2 intravenously infused over 3 hours Biological: Bevacizumab Induction therapy: 15mg/kg given intravenously every 21 days X 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Arms

Assigned Interventions

Experimental: Pemetrexed + Carboplatin + Pemetrexed

Pemetrexed and Carboplatin followed by Pemetrexed

Drug: Pemetrexed

Induction therapy: 500mg/m2 given intravenously every 21 days X 4 cycles. Maintenance therapy: 500 mg/m2 given intravenously every 21 days until disease progression or treatment discontinuation.

Other Name: ALIMTA, LY231514

Drug: Carboplatin

Induction Therapy (every 21 days X 4 cycles): Area Under the Curve (AUC)6 intravenously infused over 30 minutes.

Active Comparator: Paclitaxel + Carboplatin + Bevacizumab

Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab

Drug: Carboplatin

Induction Therapy (every 21 days X 4 cycles): Area Under the Curve (AUC)6 intravenously infused over 30 minutes.

Drug: Paclitaxel

Induction Therapy(every 21 days X 4 cycles): 200 mg/m2 intravenously infused over 3 hours

Biological: Bevacizumab

Induction therapy: 15mg/kg given intravenously every 21 days X 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Detailed Description:

This is a multicenter, randomized, open-label, Phase III trial. Eligible patients will be randomized in a 1:1 ratio to receive pemetrexed and carboplatin followed by pemetrexed or paclitaxel, carboplatin, and bevacizumab followed by bevacizumab as their study treatment. Patients randomized to Pemetrexed + Carboplatin + Pemetrexed will receive folic acid, vitamin B12, and dexamethasone as stated in the pemetrexed label. Before administration of paclitaxel, patients randomized to Paclitaxel + Carboplatin + Bevacizumab will receive premedication (dexamethasone, diphenhydramine, and cimetidine or ranitidine) as recommended in the paclitaxel label.

Eligibility

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

Criteria

Inclusion Criteria:

a histologic or cytologic diagnosis of advanced NSCLC (Stage IV from the American Joint Committee on Cancer Staging Criteria (AJCC) staging system, version 7.0, including both M1a and M1b), other than predominantly squamous cell histology, that is not amenable to curative therapy. Patients may not have received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy, including adjuvant therapy, for any stage of NSCLC.
prior radiation therapy is allowed to < 25% of the bone marrow; however, prior radiation to the whole pelvis not allowed.
good performance status
adequate organ function
estimated life expectancy of at least 12 weeks.

Exclusion Criteria:

known central nervous system (CNS) disease, other than treated brain metastasis.
major surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days prior to study or have an anticipated need for major surgery during the study.
core biopsy or other minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, and mediastinoscopy, within 7 days prior to study.
history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
currently receiving ongoing treatment with full-dose warfarin or equivalent
significant vascular disease within 6 months prior to Day 1 of Cycle 1.
evidence of bleeding diathesis or coagulopathy.
serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
serious cardiac condition, such as myocardial infarction, angina, or heart disease.
inadequately controlled hypertension
any prior history of hypertensive crisis or hypertensive encephalopathy.
serious, nonhealing wound, active ulcer, or untreated bone fracture.
another active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.
previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab (prior intravitreal administration of bevacizumab does not preclude study participation).
pregnant or breast-feeding.
history of stroke or transient ischemic attack within 6 months prior to study.
known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.
history of hemoptysis within 3 months prior to randomization.
unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
unwilling to take folic acid or vitamin B12 supplementation.
clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage . Patients with M1a disease with pleural effusions are eligible if the effusions can be adequately controlled.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948675

Contacts

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

1-317-615-4559

Show 62 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/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00948675 History of Changes
Other Study ID Numbers:	13258, H3E-US-S130
Study First Received:	July 28, 2009
Last Updated:	May 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology
Advanced Lung Cancer
Non-Small Cell Lung Cancer
Lung Cancer

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 May 23, 2012