A Study to Evaluate Bevacizumab and Chemotherapy or Tarceva in Treating Recurrent or Refractory NSCLC (Non-Small Cell Lung Cancer)

Non-Small-Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095225
• Other study ID #: OSI2950g
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2004
• Last updated: January 23, 2008
• Start date: July 2004
• Est. completion date: November 2006

Study information

• Verified date: January 2008
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00098410

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (> 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Recurrence, Local
• Non-Small-Cell Lung Carcinoma
• Recurrence

Intervention

Drug:
• Avastin (bevacizumab)

• Tarceva (erlotinib HCl)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.