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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
  • Recurrent Large Cell Lung Carcinoma
  • Recurrent Lung Adenocarcinoma
  • Recurrent Squamous Cell Lung Carcinoma
  • Stage IV Large Cell Lung Carcinoma
  • Stage IV Lung Adenocarcinoma
  • Stage IV Squamous Cell Lung Carcinoma
What is the purpose of this trial?

This randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). 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, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. 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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Patients must have histologically or cytologically proven primary non-small cell lung
cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified); disease must
be stage IV; disease may be either newly diagnosed or recurrent after previous
surgery and/or irradiation; patients with additional lesions in an ipsilateral
non-primary lobe without M1a or M1b disease will not be considered to have stage IV
disease and are not eligible

- Patients must have a computed tomography (CT) or magnetic resonance imaging (MRI)
scan of the brain to evaluate for central nervous system (CNS) disease within 42 days
prior to registration; patient must not have brain metastases unless: (1) metastases
have been treated and have remained controlled for at least two weeks following
treatment, AND (2) patient has no residual neurological dysfunction off
corticosteroids for at least 1 day

- Patients may have measurable or non-measurable disease documented by CT or MRI; the
CT from a combined positron emission tomography (PET)/CT may be used to document only
non-measurable disease unless it is of diagnostic quality; measurable disease must be
assessed within 28 days prior to registration; pleural effusions, ascites and
laboratory parameters are not acceptable as the only evidence of disease;
non-measurable disease must be assessed within 42 days prior to registration; all
disease must be assessed and documented on the Baseline Tumor Assessment Form

- Patients must have tumor tissue available for submission that is sufficient for EGFR
FISH testing and must agree to submission of these specimens; patients must also
agree to submission of specimens for other translational medicine studies; patient
must be offered participation in banking for future research

- Patients must not have received prior chemotherapy for any stage non-small cell lung
cancer; patients must not have received prior platinum-based chemotherapy for any
purpose; patient must not have received any cetuximab, gefitinib, erlotinib, or other
investigational agents that target the EGFR pathway; patients must not have received
for any purpose prior bevacizumab or other vascular endothelial growth factor
(VEGF)-related agents; patients must not have received for any purpose prior
chimerized or murine monoclonal antibody therapy or have documented presence of human
anti-mouse antibodies (HAMA)

- Prior radiation is permitted; however, patients must have recovered from all
associated toxicities at time of registration; in order to qualify as measurable,
measurable disease must be outside the previous radiation field or must have
progressed

- Time from surgical or biopsy procedures is dependent on whether it is planned for the
patient to receive bevacizumab

- For patients who are bevacizumab-appropriate AND bevacizumab is planned: at
least 28 days must have elapsed since major surgery (i.e. thoracotomy or
video-assisted thoracoscopic surgery [VATS] resection of lung cancer, open
pleural biopsy or another major surgical procedure such as abdominal surgery) or
significant traumatic injury; patients must have recovered from all associated
toxicities at the time of registration; there must be no anticipation of need
for major surgical procedures during protocol treatment; patients must not have
had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS
pericardial window within 14 days prior to registration; patients must not have
had a percutaneous fine needle aspiration (FNA), thoracentesis or central venous
access device implanted within 7 days prior to registration; for other surgical
procedures not listed here, please contact the study coordinators

- For patients who are bevacizumab-inappropriate or bevacizumab is not planned: at
least 28 days must have elapsed since major surgery (i.e. thoracotomy or VATS
resection of lung cancer, open pleural biopsy or another major surgical
procedure such as abdominal surgery) or significant traumatic injury; patients
must have recovered from all associated toxicities at the time of registration;
there must be no anticipation of need for major surgical procedures during
protocol treatment; patients must not have had a core biopsy, mediastinoscopy,
pleurodesis, VATS pleural biopsy or VATS pericardial window within 7 days prior
to registration; patients must not have had a percutaneous fine needle
aspiration (FNA), or thoracentesis within 1 day prior to registration; patients
may have had a central venous access device placed at any time prior to
registration; for other surgical procedures not listed here, please contact the
study coordinators

- Absolute neutrophil count (ANC) >= 1,500/mcl

- Platelet count >= 100,000/mcl

- Hemoglobin >= 9 g/dL

- Serum creatinine =< institutional upper limit of normal (IULN) AND calculated or
measured creatinine clearance >= 50 cc/min using the following Cockroft-Gault formula

- For patients who will be receiving bevacizumab, urine protein must be screened by
urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour
urine protein must be obtained and the level must be < 1,000 mg for patient
enrollment; the urine protein used to calculate the UPC ratio must be obtained within
14 days prior to registration; UPC or 24-hour protein is not required for patients
who will not receive bevacizumab Note: UPC ratio of spot urine is an estimation of
the 24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a
24-hour urine protein of 1 gm

- Serum bilirubin =< 2 times IULN (for patients with liver metastases, bilirubin must
be =< 5 X IULN)

- Serum glutamic oxaloacetic transaminase (SGOT) OR serum glutamate pyruvate
transaminase (SGPT) =< 2 times IULN (for patients with liver metastases, either SGOT
or SGPT must be =< 5 X IULN)

- Zubrod performance status 0-1

- Patients must not have >= grade 2 symptomatic neuropathy-sensory (National Cancer
Institute [NCI] Common Terminology Criteria version 3.0)

- Patients must not have documented evidence of acute hepatitis or have an active or
uncontrolled infection

- Patients must not have the following: history (within past 6 months) of
cerebrovascular accident (CVA), myocardial infarction or unstable angina; or at the
time of registration, uncontrolled hypertension, New York Heart Association grade 2
or greater congestive heart failure, serious cardiac arrhythmia requiring medication,
or clinically significant peripheral vascular disease

- Patients must have no known hypersensitivity to Chinese hamster ovary cell products
or other recombinant human antibodies (examples include trastuzumab [Herceptin] and
epoetin alpha)

- Patients must be willing to provide prior smoking history

- No other prior malignancy is allowed 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

- Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method; a woman is considered to be of
"reproductive potential" if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, "effective
contraception" also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures

- Patients or their legally authorized representative must be informed of the
investigational nature of this study and must sign and give written informed consent
in accordance with institutional and federal guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system

Gender: Both
Steward Physician(s)
  • Roy Herbst
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Biological
  • Bevacizumab
  • Cetuximab
Drug
  • Carboplatin
  • Paclitaxel
Other
  • Laboratory Biomarker Analysis
Physician Researcher

Investigator Name:

  • Roy Herbst

Other Information

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

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