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A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy (Docetaxel or Pemetrexed) or Tarceva (Erlotinib) Compared With Chemotherapy (Docetaxel or Pemetrexed) Alone for Treatment of Recurrent or Refractory Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-Small-Cell Lung Carcinoma, Neoplasm Recurrence, Local

Thank you

Trial Information

A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy (Docetaxel or Pemetrexed) or Tarceva (Erlotinib) Compared With Chemotherapy (Docetaxel or Pemetrexed) Alone for Treatment of Recurrent or Refractory Non-Small Cell Lung Cancer

Inclusion Criteria:

- Signed written informed consent

- Histologically or cytologically proven Stage IIIb with pleural effusion, or Stage IV,
recurrent non-squamous NSCLC that is recurrent and unresectable

- Progression after one line of platinum-based chemotherapy (patients who have received
prior docetaxel treatment are eligible to participate if there are no
contraindications for pemetrexed treatment)

- Progression after previous adjuvant chemotherapy, if therapy was completed >= 6
months prior to randomization and the patient has received one line of therapy for
recurrent disease

- (Optional) Availability of archival diagnostic tissue (paraffin tissue block or 2-10
unstained slides representative of the patient's primary cancer)

- ECOG performance status of 0, 1, or 2

- Life expectancy >= 3 months

- Measurable disease in accordance with RECIST

- Age >= 18 years

- Use of an acceptable means of contraception (potentially fertile men and women) or
documentation of infertility

Exclusion Criteria:

- More than 30 days of prior treatment with an investigational or marketed agent that
acts by EGFR inhibition (those with 30 or fewer days on an EGFR inhibitor without
disease progression are eligible for enrollment)

- Treatment with an investigational or marketed agent that acts by anti-angiogenic

- Previous treatment with more than one platinum-based chemotherapy

- Chemotherapy or radiotherapy within 28 days prior to randomization

- History of hemoptysis (> 1 teaspoon) or presence of a cavitary lesion

- Clinical history of Grade > 2 hematemesis within 6 months or Grade 1 hematemesis
within 28 days prior to randomization

- History of serious systemic disease, including myocardial infarction within the last
6 months, uncontrolled hypertension (blood pressure > 150/100 mmHg on medication),
unstable angina, New York Heart Association (NYHA) Grade II or greater congestive
heart failure, unstable symptomatic arrhythmia requiring medication (patients with
chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular
tachycardia are eligible), or Grade II or greater peripheral vascular disease

- History or clinical evidence of CNS or brain metastases or CNS bleeding

- History or clinical evidence of hemorrhagic or thrombotic stroke within the 6 months
prior to randomization

- Centrally located lesions and lesions that abut major blood vessels

- Ongoing treatment with full-dose warfarin (or its equivalent) or heparin (or its
equivalent; e.g., Lovenox(R))

- In-patient surgical procedure, open biopsy, or significant traumatic injury within 28
days prior to randomization

- Minor surgical procedure, fine needle aspirations, or core biopsy within 7 days prior
to randomization

- Anticipation of need for a major surgical procedure during the course of the study

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to take oral medication or requirement for IV alimentation or total
parenteral nutrition with lipids, or prior surgical procedures affecting absorption

- Any of the following abnormal hematologic values (within 1 week prior to
randomization): ANC <= 1,500 cells/uL; platelet count <= 100,000 cells/uL;
Hemoglobin <= 9.0 g/dL; International normalized ratio (INR) > 1.5 x upper limit
of normal (ULN)

- For patients who will receive docetaxel, any of the following abnormal liver function
tests (within 1 week prior to randomization): Serum bilirubin greater than ULN;
Albumin <= 2.5 g/dL; Serum ALT >= 1.5 x ULN; Serum AST >= 1.5 x ULN; Alkaline
phosphatase >= 2.5 x ULN

- Other baseline laboratory values: Serum creatinine > 2.0 x ULN; Uncontrolled
hypercalcemia ( > 11.5 mg/dL); Urinary protein/creatinine ratio >= 1 (spot urine)
or clinically significant impairment of renal function; Estimated creatinine
clearance < 45 mL/min (for patients who will receive pemetrexed)

- Any active systemic bacterial, fungal, or viral infection, including known hepatitis
C and HIV

- Pregnant or breast-feeding

- Presence of another cancer within 5 years prior to randomization, except for
adequately treated carcinoma in situ of the cervix or non-melanomatous skin cancer

- Evidence of confusion or disorientation, or history of major psychiatric illness that
may impair the patient's understanding of the Informed Consent Form

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and preliminary efficacy of combining bevacizumab with chemotherapy or Tarceva relative to chemotherapy alone on patients with previously treated advanced non-small cell lung cancer.

Principal Investigator

Vince O'Neill, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

November 2006

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Neoplasm Recurrence, Local
  • Recurrent or refractory non-small cell lung cancer
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Recurrence, Local
  • Recurrence



Virginia Mason Medical Center Seattle, Washington  98111
Florida Cancer Specialists Fort Myers, Florida  33901
Maine Center for Cancer Medicine and Blood Disorders Scarborough, Maine  04074
Mid Dakota Clinic Bismarck, North Dakota  58501
University of Chicago Chicago, Illinois  60637
UC Davis Cancer Center Sacramento, California  95817
Bay Area Cancer Research Group Concord, California  94520
Cancer Research of Long Island Great Neck, New York  11023
The West Cancer Clinic Memphis, Tennessee  38120
Kaiser Permanente Northwest Region Portland, Oregon  97227
Hematology Oncology Consultants Naperville, Illinois  60540
Comprehensive Blood and Cancer Center (TORI) Bakersfield, California  93309
Virginia K. Crosson Cancer Center (TORI) Fullerton, California  92835
California Cancer Center, Inc Greenbrae, California  94904
Wilshire Oncology Medical Group (TORI) Laverne, California  91750
Pacific Shores Medical Group (TORI) Long Beach, California  90813-3244
UCLA Medical Center PVUB 3360 Los Angeles, California  90095
Central Hematology Oncology Medical Group (TORI) Monterey Park, California  91754
North Valley Hematology/Oncology Medical Group (TORI) Northridge, California  91328
Ventura County Hematology-Oncology Specialists (TORI) Oxnard, California  93030
Cancer Care Associates Medical Group (TORI) Redondo Beach, California  90277
Kaiser Permanente/ San Diego San Diego, California  92120
Sansum Santa Barbara Medical Foundation Clinic (TORI) Santa Barbara, California  93105
Santa Barbara Hematology Oncology Medical Group, Inc (TORI) Santa Barbara, California  93105
Kaiser Permanente Northern CA Vallejo, California  94589
San Diego Cancer Center Medical Group (TORI) Vista, California  92081
Comprehensive Cancer Care Specialist at Boca Raton Boca Raton, Florida  33428
The Florida Cancer Institute(TORI) Orlando, Florida  32804
MD Anderson Cancer Ctr- Orlando Orlando, Florida  32806
Hematology and Oncology of Northeast Georgia, PC (TORI) Athens, Georgia  30607
Medical Oncology Associates, PC (TORI) Augusta, Georgia  30901
Suburban Hematology-Oncology Associates (TORI) Lawrenceville, Georgia  30045
WellStar Cancer Research Office Marietta, Georgia  30060
Atlanta Cancer Care (TORI) Roswell, Georgia  30076
Rush-Presbyteriam Chicago, Illinois  60612
Loyola Univ. Medical Center Maywood, Illinois  60153
Oncoloy Hematology Associates of Central Illinois, PC (TORI) Peoria, Illinois  61615
Norton Healthcare Louisville Oncology Louisville, Kentucky  40202
Ochsner Cancer Inst. New Orleans, Louisiana  70121
Methodist Cancer Center-Oncology Research Omaha, Nebraska  68114
Comprehensive Cancer Centers of Nevada (TORI) Las Vegas, Nevada  89109
Summit Medical Group Overlook Oncology Center Summit, New Jersey  07901
Northwestern Carolina Oncology and Hematology Hickory, North Carolina  28603
Earle A. Chiles Research Institute Portland, Oregon  97213
Univ. of Pittsburgh Cancer Center Inst. Pittsburgh, Pennsylvania  15232
University of Tenn. Cancer Ins Memphis, Tennessee  38104
M.D. Anderson Houston, Texas  77030
Internal Medicine Associates of Yakima Yakima, Washington  98902