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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Malignant Pleural Effusion, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

PFS

Outcome Description:

The product limit estimator developed by Kaplan and Meier will be used.

Outcome Time Frame:

Time between randomization and initial failure (disease progression or death), assessed up to 6 months

Safety Issue:

No

Principal Investigator

Rogerio Lilenbaum

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02820

NCT ID:

NCT00118183

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Lung
  • Adenosquamous Cell Lung Cancer
  • Large Cell Lung Cancer
  • Malignant Pleural Effusion
  • Recurrent Non-Small Cell Lung Cancer
  • Squamous Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion
  • Pleural Effusion, Malignant

Name

Location
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140