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Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second Line Treatment of Stage IIIB or IV NSCLC

Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second Line Treatment of Stage IIIB or IV NSCLC

This phase II trial will address the issues of bevacizumab treatment duration and treatment
safety by incorporating bevacizumab into a variation of the ECOG reference regimen as
first-line therapy for patients with non-squamous non-small cell lung cancer. Following
disease progression or treatment failure, the potential benefit of continued bevacizumab
therapy will be tested by randomizing patients to two treatment arms, including second-line
chemotherapy with or without further bevacizumab.

For first-line treatment, a regimen of carboplatin, docetaxel, and bevacizumab followed by
maintenance bevacizumab therapy will be given to all patients. Upon disease progression or
treatment failure, patients will be randomized to one of two second-line regimens:
pemetrexed plus bevacizumab or pemetrexed monotherapy.

Inclusion Criteria:

- Age ≥ 18 years

- Histologically or cytologically confirmed stage IIIB with malignant pleural effusion
or stage IV NSCLC except squamous-cell carcinoma.

- Measurable disease defined by RECIST.

- Adequate organ function

- Peripheral neuropathy ≤ grade 1

- ECOG Performance Status 0-1

- Estimated survival of ≥ 12 weeks

- Provide written informed consent

Exclusion Criteria:

- Prior chemotherapy for advanced NSCLC

- Neoadjuvant or adjuvant treatment within 6 months of registration

- Prior radiation therapy within 3 weeks of registration. All side effects must have
resolved by registration

- Prior treatment with an investigational or marketed agent that acts by
antiangiogenesis mechanisms

- Large ( > 4 cm) centrally located lesions or large lesions in close proximity to
major blood vessels unless treated with palliative radiation

- Brain metastases or leptomeningeal disease, except for patients who have had a
resection and/or completed a course of cranial irradiation, have no worsening CNS
symptoms, and have discontinued all corticosteroids for that indication for at least
1 month prior to registration

- History of gross hemoptysis (defined as bright red blood of at least ½ teaspoon or
2.5 mL per episode) within 3 months of registration unless definitively treated with
surgery, radiation, arteriographic embolization, or endobronchial interventions at
least 4 weeks prior to registration

- Presence of cavitary lesion

- Presence of squamous histology (mixed tumors will be categorized by the predominant
cell type unless small cell elements are present, in which case the patient is
ineligible; sputum cytology alone is not acceptable)

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of
registration or anticipation of need for major surgical procedure during the course
of the study

- Minor surgical procedures, fine needle aspirations or core biopsies within

1 week prior to registration

- Current, ongoing therapeutic anticoagulation with full-dose warfarin or its

- Current or recent (within 10 days of the first dose of study treatment) use of
aspirin (at least 325 mg/day) or other NSAIDs with anti-platelet activity or
treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix),
or cilostazol (Pletal)

- History of prior malignancy within the past 3 years except for curatively treated
basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated
localized prostate cancer with a current PSA of < 1.0 mg/dL on two successive
evaluations, at least 3 months apart, with the most recent evaluation no more than 4
weeks prior to registration

- History of serious systemic disease

- Pregnancy or women who are breast-feeding. Women of child-bearing potential and
non-vasectomized men must agree to use effective methods of birth control during and
3 months following treatment period. Women of child- bearing potential must have a
negative pregnancy test.

- History of severe hypersensitivity reaction to docetaxel or any other drugs
formulated with polysorbate 80

- Any other medical condition, including mental illness or substance abuse, which in
the judgment of the investigator, is likely to interfere with a patient's ability to
provide informed consent, cooperate, and participate in the study, or to interfere
with the interpretation of the results

- Use of any investigational agent within 4 weeks prior to registration

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV non-small cell lung cancer

Outcome Time Frame:

An expected average of 2 years

Safety Issue:


Principal Investigator

Chandra P Belani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine


United States: Food and Drug Administration

Study ID:

PSHCI 08-009



Start Date:

December 2008

Completion Date:

July 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Stage IIIB non small cell lung cancer
  • Stage IV non small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Penn State College of Medicine, Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033