A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer

NCT ID: NCT00735696

Last Updated: 2014-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-01-31

Brief Summary

The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB or IV non-small cell lung cancer

Detailed Description

Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers. The advanced stages are associated with poor survival rates, a median survival rate of approximately 3.9 months if left untreated.

Angiogenesis is a process for wound healing and restoring blood flow to tissues after injury. It is the physiological process involving the growth of new blood vessels from pre-existing vessels. Angiogenesis may be promoted by growth factors and in diseases such as cancer, where growth factors are over expressed, the body loses the ability to maintain a balanced angiogenesis. This may embellish the existing supplies of blood; potentially increasing the delivery of oxygen and nutrients supplies for cancer growth and survival.

Ramucirumab is an angiogenesis inhibitor; and is believed to block the promotion of the growth factor to form new blood vessels, thus reducing the blood supply to the cancer cells.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Lung; NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ramucirumab + paclitaxel + carboplatin

Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle).

In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks.

Group Type: EXPERIMENTAL

Ramucirumab

Intervention Type: BIOLOGICAL

10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle.

Paclitaxel

Intervention Type: DRUG

200 milligrams per meter squared (mg/m\^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles.

Carboplatin

Intervention Type: DRUG

Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6.

Interventions

Ramucirumab

10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle.

Intervention Type: BIOLOGICAL

Paclitaxel

200 milligrams per meter squared (mg/m\^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles.

Intervention Type: DRUG

Carboplatin

Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6.

Intervention Type: DRUG

Other Intervention Names

IMC-1121B; LY3009806

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed NSCLC
• Advanced NSCLC
• Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors [RECIST 1.0])
• Eastern Cooperative Oncology Group (ECOG) Performance Status is ≤ 1
• Age ≥ 18 years
• Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/microliter (μL)
• Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN)
• Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) > 60 mL/minute, and urine dipstick for protein < 1+ (ie, either 0 or trace)
• Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN
• Adequate contraception
• Signed informed consent

Exclusion Criteria

• Untreated CNS metastases
• Prior bevacizumab therapy
• Radiologically documented evidence of major blood vessel invasion or encasement by cancer
• Prior systemic chemotherapy for Stage IIIB/IV NSCLC
• Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC < 1 year prior
• Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix
• Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
• Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Uncontrolled thrombotic or hemorrhagic disorders
• Poorly-controlled hypertension
• Chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function
• History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)
• Serious non-healing wound, ulcer, or bone fracture
• Undergone major surgery or subcutaneous venous access device placement. Post-operative bleeding complications or wound complications from a surgical procedures performed in the last 2 months
• Elective or a planned major surgery to be performed during the course of the trial
• Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])
• If female, is pregnant or lactating
• Radiographic evidence of intratumor cavitation
• Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Beverly Hills, California, United States

ImClone Investigational Site

San Francisco, California, United States

ImClone Investigational Site

Aurora, Colorado, United States

ImClone Investigational Site

New York, New York, United States

ImClone Investigational Site

The Bronx, New York, United States

ImClone Investigational Site

San Antonio, Texas, United States

ImClone Investigational Site

Seattle, Washington, United States

ImClone Investigational Site

Cambridge, , United Kingdom

ImClone Investigational Site

London, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

2007-006715-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CP12-0708

Identifier Type: OTHER

Identifier Source: secondary_id

I4T-IE-JVBJ

Identifier Type: OTHER

Identifier Source: secondary_id

13914

Identifier Type: -

Identifier Source: org_study_id