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