S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Southwest Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00368992
First received: August 24, 2006
Last updated: July 18, 2011
Last verified: June 2011
  Purpose

RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with paclitaxel, carboplatin, and bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and bevacizumab works in treating patients with advanced non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Biological: cetuximab
Drug: carboplatin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Frequency and severity of hemorrhage toxicities [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: August 2006
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the frequency and severity of hemorrhage toxicities in patients with advanced non-small cell lung cancer treated with induction therapy comprising cetuximab, paclitaxel, carboplatin, and bevacizumab followed by maintenance therapy comprising cetuximab and bevacizumab.

Secondary

  • Evaluate progression-free and overall survival and response rates (confirmed and unconfirmed, complete and partial) in patients treated with this regimen.
  • Determine the frequency and severity of nonhemorrhage toxicities in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance therapy: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced primary non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

    • Newly diagnosed selected stage IIIB disease

      • T4 lesion due to malignant pleural effusion
      • Any N
      • M0
    • Newly diagnosed stage IV disease

      • Any T
      • Any N
      • M1 (i.e., distant metastases present)
    • Recurrent disease after prior surgery and/or radiotherapy (considered stage IV disease)
  • Any 1 of the following cellular types:

    • Adenocarcinoma
    • Large cell carcinoma
    • Unspecified
  • No tumor with > 50% squamous cell components
  • Measurable or nonmeasurable disease as measured by CT scan, MRI, x-ray, or physical exam

    • Disease must be outside the previous radiation field, area of surgical resection, or a new lesion must be present
    • Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 9 mg/dL
  • Creatinine normal
  • Creatinine clearance ≥ 50 mL/min
  • Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection
  • SGOT or SGPT ≤ 2 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN
  • Alkaline phosphatase ≤ 2 times ULN
  • INR ≤ 1.5
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
  • No symptomatic neuropathy (sensory) ≥ grade 2
  • No documented evidence of acute hepatitis
  • No active or uncontrolled infection
  • No history of any of the following:

    • Cerebral vascular accident within the past 6 months
    • Myocardial infarction within the past 6 months
    • Unstable angina within the past 6 months
    • Uncontrolled hypertension
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Clinically significant peripheral vascular disease
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No hemoptysis ≥ ½ teaspoon within the past 3 months
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No significant traumatic injury within the past 28 days
  • No evidence of bleeding diathesis or coagulopathy
  • No other prior malignancy within the past 5 years except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Adequately treated stage I or II cancer for which the patient is currently in complete remission
  • No documented presence of human anti-mouse antibodies (HAMA)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 3 weeks since prior radiotherapy
  • At least 4 weeks since prior surgery (e.g., thoracic or other major surgery) and no anticipated need for surgery during study treatment
  • At least 28 days since prior open biopsy
  • At least 7 days since prior core biopsy
  • No prior systemic chemotherapy or biologic therapy for NSCLC
  • No prior adjuvant therapy for NSCLC
  • No prior cetuximab, gefitinib, erlotinib, or other investigational agents that target the epidermal growth factor receptor (EGFR) pathway
  • No prior vascular endothelial growth factor (VEGF)-related agents
  • No prior chimerized or murine monoclonal antibody therapy
  • No concurrent full-dose anticoagulation therapy

    • Concurrent low-dose (1 mg daily) warfarin allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368992

  Show 140 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Edward S. Kim M.D. Anderson Cancer Center
Study Chair: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Gandara D, Kim ES, Herbst RS, et al.: S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study. [Abstract] J Clin Oncol 27 (Suppl 15): A-8015, 2009.
Franklin WA, Gandara DR, Kim ES, et al.: SWOG S0342 and S0536: expression of EGFR protein and markers of epithelial-mesenchymal transformation (EMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-11076, 2009.
Mack PC, Holland WS, Redman M, et al.: KRAS mutation analysis in cetuximab-treated advanced stage non-small cell lung cancer (NSCLC): SWOG experience with S0342 and S0536. [Abstract] J Clin Oncol 27 (Suppl15): A-8022, 2009.

Responsible Party: Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier: NCT00368992     History of Changes
Other Study ID Numbers: CDR0000495363, U10CA032102, SWOG-S0536
Study First Received: August 24, 2006
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
large cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Cetuximab
Carboplatin
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014