Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828841
• Other study ID #: AC01L08
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2009
• Last updated: October 11, 2013
• Start date: December 2008
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: Accelerated Community Oncology Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising and should be tested further. The study will also look at what side effects may occur.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent before study-related activities

• Histologically or cytologically confirmed Stage IIIb with cytologically documented malignant pleural or pericardial effusion, Stage IV, or recurrent non-smal cell lung cancer (NSCLC) after resection or radiation for earlier stage disease

• Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid Tumors [RECIST] guidelines)

• Male or female = 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• White blood count = 3 x 10(9)/L with neutrophils = 1.5 x 10(9)/L, platelet count = 100 x 10(9)/L, and hemoglobin = 9.5 g/dL

• Total bilirubin = 1.5 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN or = 5 x ULN in patients with liver mets

• Serum creatinine = 1.25 x ULN

• Recovery from prior surgery or radiation to Grade 1 or better toxicity

• Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 wks after the study in such a manner that the risk of pregnancy is minimized

• WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration

Exclusion Criteria:

• WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study

• Women who are pregnant or breastfeeding

• Women with a positive pregnancy test during screening or prior to study drug administration

• Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential

• Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is allowed if completed at least 12 months before study entry

• Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior treatment with monoclonal antibodies targeting receptors other than the EGFR, such as bevacizumab, is allowed if completed > 30 days prior to randomization

• Treatment with any investigational agent(s) within 4 weeks prior to study entry

• Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted therapy) other than protocol therapy

• Carcinoid, atypical carcinoid or small cell lung cancer

• Symptomatic or uncontrolled mets in the central nervous system

• Prior invasive malignancy requiring ongoing therapy within the past year

• Active infection (infection requiring intravenous [IV] antibiotics), including active tuberculosis, known and declared HIV

• Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment

• Known allergic/hypersensitivity reaction to any of the components of study treatments

• Peripheral neuropathy = Grade 2, as assessed by Common Terminology Criteria for Adverse Events, version 3.0

• History of significant neurologic or psychiatric disorders including but not limited to dementia, seizures, and bipolar disorder

• Medical or psychological condition that would not permit the patient to complete the study or sign informed consent

• Known drug abuse

Patients of all races and ethnic groups are eligible for this trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
• Paclitaxel
Paclitaxel 200 mg/m2 Day 1 every 21 days
• Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
• Gemcitabine
Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
• Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days

Locations

Country	Name	City	State
United States	Family Medicine of Vincennes	Vincennes	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Accelerated Community Oncology Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival by Treatment Arm		Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.	No
Secondary	1-year Survival by Treatment Arm		Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.	No
Secondary	Overall Survival by Histology		Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.	No