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A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer



- Evaluate the frequency and severity of hemorrhage toxicities in patients with advanced
non-small cell lung cancer treated with induction therapy comprising cetuximab,
paclitaxel, carboplatin, and bevacizumab followed by maintenance therapy comprising
cetuximab and bevacizumab.


- Evaluate progression-free and overall survival and response rates (confirmed and
unconfirmed, complete and partial) in patients treated with this regimen.

- Determine the frequency and severity of nonhemorrhage toxicities in patients treated
with this regimen.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15
and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over
30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

- Maintenance therapy: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and
bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed advanced primary non-small cell lung cancer
(NSCLC) meeting 1 of the following criteria:

- Newly diagnosed selected stage IIIB disease

- T4 lesion due to malignant pleural effusion

- Any N

- M0

- Newly diagnosed stage IV disease

- Any T

- Any N

- M1 (i.e., distant metastases present)

- Recurrent disease after prior surgery and/or radiotherapy (considered stage IV

- Any 1 of the following cellular types:

- Adenocarcinoma

- Large cell carcinoma

- Unspecified

- No tumor with > 50% squamous cell components

- Measurable or nonmeasurable disease as measured by CT scan, MRI, x-ray, or physical

- Disease must be outside the previous radiation field, area of surgical
resection, or a new lesion must be present

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

- No known brain metastases


- Zubrod performance status 0-1

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Hemoglobin ≥ 9 mg/dL

- Creatinine normal

- Creatinine clearance ≥ 50 mL/min

- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine

- SGOT or SGPT ≤ 2 times upper limit of normal (ULN)

- Bilirubin ≤ 2 times ULN

- Alkaline phosphatase ≤ 2 times ULN

- INR ≤ 1.5

- Not pregnant or nursing

- Negative pregnancy test

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

- No symptomatic neuropathy (sensory) ≥ grade 2

- No documented evidence of acute hepatitis

- No active or uncontrolled infection

- No history of any of the following:

- Cerebral vascular accident within the past 6 months

- Myocardial infarction within the past 6 months

- Unstable angina within the past 6 months

- Uncontrolled hypertension

- New York Heart Association class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Clinically significant peripheral vascular disease

- No serious or nonhealing wound, ulcer, or bone fracture

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- No hemoptysis ≥ ½ teaspoon within the past 3 months

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- No significant traumatic injury within the past 28 days

- No evidence of bleeding diathesis or coagulopathy

- No other prior malignancy within the past 5 years except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

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

- No documented presence of human anti-mouse antibodies (HAMA)


- See Disease Characteristics

- Recovered from prior therapy

- At least 3 weeks since prior radiotherapy

- At least 4 weeks since prior surgery (e.g., thoracic or other major surgery) and no
anticipated need for surgery during study treatment

- At least 28 days since prior open biopsy

- At least 7 days since prior core biopsy

- No prior systemic chemotherapy or biologic therapy for NSCLC

- No prior adjuvant therapy for NSCLC

- No prior cetuximab, gefitinib, erlotinib, or other investigational agents that target
the epidermal growth factor receptor (EGFR) pathway

- No prior vascular endothelial growth factor (VEGF)-related agents

- No prior chimerized or murine monoclonal antibody therapy

- No concurrent full-dose anticoagulation therapy

- Concurrent low-dose (1 mg daily) warfarin allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and severity of hemorrhage toxicities

Safety Issue:


Principal Investigator

Edward S. Kim

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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