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A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 bevacizumab and cetuximab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer (NSCLC). PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or recurrent non-small cell lung cancer.

Date & Status

Suspended

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),
including any of the following subtypes:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified

- Newly diagnosed stage IV disease OR recurrent disease after prior surgery and/or
irradiation

- Patients with additional lesions in an ipsilateral non-primary lobe without M1a
or M1b disease are not considered to have stage IV disease and are not eligible

- Measurable or non-measurable disease documented by CT scan or MRI

- Pleural effusions, ascites, and laboratory parameters are not acceptable as the
only evidence of disease

- Measurable disease must be outside a previously irradiated field or must have
progressed

- Patients must not have received prior chemotherapy for any stage NSCLC

- Brain metastases allowed provided they have been controlled for ≥ 2 weeks after
completion of treatment and there is no residual neurological dysfunction while off
corticosteroids for at least 1 day

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Serum creatinine normal

- Creatinine clearance ≥ 50 mL/min

- Urine protein:creatinine ratio ≤ 0.5 OR 24-hour urine protein < 1,000 mg (for
patients who will be receiving bevacizumab)

- Serum bilirubin ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN for patients
with liver metastases)

- SGOT OR SGPT ≤ 2 times ULN (≤ 5 times ULN for patients with liver metastases)

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 3-6 months after
completion of study treatment

- Agrees to submission of specimens that is sufficient for EGFR FISH testing and other
translational medicine studies

- Willing to provide prior smoking history

- No significant traumatic injury within the past 28 days

- No symptomatic sensory neuropathy ≥ grade 2 as assessed by NCI CTCAE v3.0

- No documented presence of human anti-mouse antibodies

- No documented evidence of acute hepatitis

- No active or uncontrolled infection

- None of the following within the past 6 months:

- Cerebrovascular accident, myocardial infarction, or unstable angina

- Uncontrolled hypertension

- NYHA class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Clinically significant peripheral vascular disease

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies (e.g., trastuzumab [Herceptin®] or epoetin alpha)

- No other prior malignancy except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer from which the patient is currently in
complete remission

- Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Prior radiotherapy allowed provided patients have recovered from all associated
toxicities at the time of study registration

- No prior cetuximab, gefitinib, erlotinib, or other investigational agents that target
the EGFR pathway

- Patients must not have received prior platinum-based chemotherapy for any purpose

- No prior bevacizumab or VEGF-related agents

- No prior chimerized or murine monoclonal antibody therapy

- At least 28 days since prior surgery (thoracic or other major surgeries) or open
biopsy and recovered (for patients who are bevacizumab-appropriate AND bevacizumab is
planned)

- More than 7 days since prior core biopsy

- No concurrent major surgical procedures

Gender: Both
Steward Physician(s)
  • Roy S. Herbst, MD, PhD
Facilities
  • Holy Family Hospital - Suspended
Trial Interventions
Biological
  • bevacizumab
  • cetuximab
Drug
  • carboplatin
  • paclitaxel
Physician Researcher

Investigator Name:

  • Roy S. Herbst, MD, PhD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00946712
Volunteers:  Not Accepting Healthy Volunteers

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