Clinical trial NCT00095225: A Study to Evaluate Bevacizumab and Chemotherapy or Tarceva in Treating Recurrent or Refractory NSCLC (Non-Small Cell Lung Cancer)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Neoplasm Recurrence, Local
Keywords: Recurrent or refractory non-small cell lung cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-02
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This Phase II, multicenter, randomized trial is designed to make preliminary evaluations of the efficacy of combining bevacizumab with chemotherapy (docetaxel or pemetrexed) or Tarceva relative to chemotherapy (docetaxel or pemetrexed) alone in patients with previously treated advanced NSCLC.


Eligibility criteria: 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 mechanisms
* Previous treatment with more than one platinum-based chemotherapy
* Chemotherapy or radiotherapy within 28 days prior to randomization
* History of hemoptysis (\&gt; 1 teaspoon) or presence of a cavitary lesion
* Clinical history of Grade \&gt; 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 \&gt; 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) \&gt; 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 \&gt; 2.0 x ULN; Uncontrolled hypercalcemia ( \&gt; 11.5 mg/dL); Urinary protein/creatinine ratio \>= 1 (spot urine) or clinically significant impairment of renal function; Estimated creatinine clearance \&lt; 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

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center (TORI)
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Fullerton
country: United States
facility: Virginia K. Crosson Cancer Center (TORI)
state: California
city: Greenbrae
country: United States
facility: California Cancer Center, Inc
state: California
city: Laverne
country: United States
facility: Wilshire Oncology Medical Group (TORI)
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group (TORI)
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center PVUB 3360
state: California
city: Monterey Park
country: United States
facility: Central Hematology Oncology Medical Group (TORI)
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Medical Group (TORI)
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists (TORI)
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group (TORI)
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente/ San Diego
state: California
city: Santa Barbara
country: United States
facility: Sansum Santa Barbara Medical Foundation Clinic (TORI)
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematology Oncology Medical Group, Inc (TORI)
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Northern CA
state: California
city: Vista
country: United States
facility: San Diego Cancer Center Medical Group (TORI)
state: California
city: Boca Raton
country: United States
facility: Comprehensive Cancer Care Specialist at Boca Raton
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: The Florida Cancer Institute(TORI)
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Ctr- Orlando
state: Florida
city: Athens
country: United States
facility: Hematology and Oncology of Northeast Georgia, PC (TORI)
state: Georgia
city: Augusta
country: United States
facility: Medical Oncology Associates, PC (TORI)
state: Georgia
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates (TORI)
state: Georgia
city: Marietta
country: United States
facility: WellStar Cancer Research Office
state: Georgia
city: Roswell
country: United States
facility: Atlanta Cancer Care (TORI)
state: Georgia
city: Chicago
country: United States
facility: Rush-Presbyteriam
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Maywood
country: United States
facility: Loyola Univ. Medical Center
state: Illinois
city: Naperville
country: United States
facility: Hematology Oncology Consultants
state: Illinois
city: Peoria
country: United States
facility: Oncoloy Hematology Associates of Central Illinois, PC (TORI)
state: Illinois
city: Louisville
country: United States
facility: Norton Healthcare Louisville Oncology
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Cancer Inst.
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine and Blood Disorders
state: Maine
city: Omaha
country: United States
facility: Methodist Cancer Center-Oncology Research
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada (TORI)
state: Nevada
city: Summit
country: United States
facility: Summit Medical Group Overlook Oncology Center
state: New Jersey
city: Great Neck
country: United States
facility: Cancer Research of Long Island
state: New York
city: Hickory
country: United States
facility: Northwestern Carolina Oncology and Hematology
state: North Carolina
city: Bismarck
country: United States
facility: Mid Dakota Clinic
state: North Dakota
city: Portland
country: United States
facility: Earle A. Chiles Research Institute
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest Region
state: Oregon
city: Pittsburgh
country: United States
facility: Univ. of Pittsburgh Cancer Center Inst.
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tenn. Cancer Ins
state: Tennessee
city: Memphis
country: United States
facility: The West Cancer Clinic
state: Tennessee
city: Houston
country: United States
facility: M.D. Anderson
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Yakima
country: United States
facility: Internal Medicine Associates of Yakima
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Vince O'Neill, M.D.
role: STUDY_DIRECTOR
References: