Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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Brief Title

Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Official Title

A Phase II Trial of Docetaxel Plus Cetuximab and Docetaxel Plus Bortezomib (NSC #681239, IND #58443) in Advanced Non-Small Cell Lung Cancer Patients With Performance Status (PS) 2

Brief Summary

      This randomized phase II trial is studying how well giving docetaxel together with either
      cetuximab or bortezomib works as first-line therapy in treating patients with stage III or
      stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in
      different ways. Some find tumor cells and kill them or carry tumor-killing substances to
      them. Others interfere with the ability of tumor cells to grow and spread. Bortezomib may
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      docetaxel together with either cetuximab or bortezomib may be effective as first-line therapy
      in treating non-small cell lung cancer.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate the progression free survival (PFS), defined as the time between study entry
      and disease progression or death, for each of the two combination regimens.

      SECONDARY OBJECTIVES:

      I. To determine the overall response rate of each regimen. II. To evaluate the overall
      survival distributions associated with each regimen.

      III. To evaluate the toxicities of each regimen.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

      Arm I: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cetuximab IV
      over 1-2 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 courses in the
      absence of disease progression or unacceptable toxicity. Patients with responding or stable
      disease after 4 courses receive cetuximab alone as above in the absence of disease
      progression or unacceptable toxicity.

      Arm II: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 1,
      8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease
      progression or unacceptable toxicity. Patients with responding or stable disease after 4
      courses receive bortezomib alone as above in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed monthly for 1 year, every 2 months
      for 2 years, and then every 4 months for 3 years.

      PROJECTED ACCRUAL: A total of 62 patients (31 per treatment arm) will be accrued for this
      study within 6-11 months.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

PFS

Secondary Outcome

 Overall response rate

Condition

Adenocarcinoma of the Lung

Intervention

docetaxel

Study Arms / Comparison Groups

 Arm I
Description:  Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cetuximab IV over 1-2 hours on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 4 courses receive cetuximab alone as above in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

62

Start Date

July 2005


Primary Completion Date

April 2007

Eligibility Criteria

        Inclusion Criteria:

          -  All patients must have histologically or cytologically documented non-small cell
             carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these
             types)

          -  Patients with stage IV disease are eligible

          -  Patients with stage IIIB due to a malignant pleural effusion or supraclavicular node
             involvement are eligible (IIIB patients eligible for CALGB protocols of combined
             chemotherapy and thoracic radiotherapy are not eligible)

          -  Patients with known CNS metastases who have received therapy (surgery, XRT, gamma
             knife), and are neurologically stable and off steroids by the time of enrollment are
             eligible if they are not on enzyme-inducing anticonvulsants; patients with
             leptomeningeal disease are not eligible

          -  Documentation of PS 2 must be noted on form C-1392

          -  Patients must have measurable or non-measurable disease

          -  Measurable disease (target lesions): lesions that can be accurately measured in at
             least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional
             techniques or as ≥ 10 mm with spiral CT scan

          -  Non-measurable disease (non-target lesions): all other lesions, including small
             lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral
             CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable
             include the following:

               -  Bone lesions

               -  Ascites

               -  Pleural/pericardial effusion

               -  Lymphangitis cutis/pulmonis

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

          -  No prior systemic treatment for advanced NSCLC is permitted; prior treatment for
             early-stage disease (adjuvant) or for locally-advanced stage III disease is allowed if
             completed at least 12 months prior to registration

          -  Patients must have recovered (all toxicities ≤ grade 1) from prior surgery and/or
             radiotherapy

          -  No prior therapy which specifically and directly targets the EGFR pathway

          -  No prior severe infusion reactions to a monoclonal antibody

          -  No ≥ grade 2 peripheral neuropathy

          -  Non-pregnant and non-nursing

          -  No concurrent treatment with any other investigational therapy

          -  Granulocytes ≥ 1,500/μl

          -  Platelets ≥ 100,000/μl

          -  Serum creatinine ≤ ULN

          -  Bilirubin ≤ ULN

          -  AST ≤ ULN
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rogerio Lilenbaum, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00118183

Organization ID

NCI-2012-02820

Secondary IDs

CALGB-30402

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Rogerio Lilenbaum, Principal Investigator, Cancer and Leukemia Group B


Verification Date

June 2013