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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00095225

Collaborator

(none)

122

Enrollment

Locations

Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Carcinoma Neoplasm Recurrence, Local	Drug: Avastin (bevacizumab) Drug: Tarceva (erlotinib HCl)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2004

Actual Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Blood and Cancer Center (TORI)	Bakersfield	California	United States	93309
2	Bay Area Cancer Research Group	Concord	California	United States	94520
3	Virginia K. Crosson Cancer Center (TORI)	Fullerton	California	United States	92835
4	California Cancer Center, Inc	Greenbrae	California	United States	94904
5	Wilshire Oncology Medical Group (TORI)	Laverne	California	United States	91750
6	Pacific Shores Medical Group (TORI)	Long Beach	California	United States	90813-3244
7	UCLA Medical Center PVUB 3360	Los Angeles	California	United States	90095
8	Central Hematology Oncology Medical Group (TORI)	Monterey Park	California	United States	91754
9	North Valley Hematology/Oncology Medical Group (TORI)	Northridge	California	United States	91328
10	Ventura County Hematology-Oncology Specialists (TORI)	Oxnard	California	United States	93030
11	Cancer Care Associates Medical Group (TORI)	Redondo Beach	California	United States	90277
12	UC Davis Cancer Center	Sacramento	California	United States	95817
13	Kaiser Permanente/ San Diego	San Diego	California	United States	92120
14	Sansum Santa Barbara Medical Foundation Clinic (TORI)	Santa Barbara	California	United States	93105
15	Santa Barbara Hematology Oncology Medical Group, Inc (TORI)	Santa Barbara	California	United States	93105
16	Kaiser Permanente Northern CA	Vallejo	California	United States	94589
17	San Diego Cancer Center Medical Group (TORI)	Vista	California	United States	92081
18	Comprehensive Cancer Care Specialist at Boca Raton	Boca Raton	Florida	United States	33428
19	Florida Cancer Specialists	Fort Myers	Florida	United States	33901
20	The Florida Cancer Institute(TORI)	Orlando	Florida	United States	32804
21	MD Anderson Cancer Ctr- Orlando	Orlando	Florida	United States	32806
22	Hematology and Oncology of Northeast Georgia, PC (TORI)	Athens	Georgia	United States	30607
23	Medical Oncology Associates, PC (TORI)	Augusta	Georgia	United States	30901
24	Suburban Hematology-Oncology Associates (TORI)	Lawrenceville	Georgia	United States	30045
25	WellStar Cancer Research Office	Marietta	Georgia	United States	30060
26	Atlanta Cancer Care (TORI)	Roswell	Georgia	United States	30076
27	Rush-Presbyteriam	Chicago	Illinois	United States	60612
28	University of Chicago	Chicago	Illinois	United States	60637
29	Loyola Univ. Medical Center	Maywood	Illinois	United States	60153
30	Hematology Oncology Consultants	Naperville	Illinois	United States	60540
31	Oncoloy Hematology Associates of Central Illinois, PC (TORI)	Peoria	Illinois	United States	61615
32	Norton Healthcare Louisville Oncology	Louisville	Kentucky	United States	40202
33	Ochsner Cancer Inst.	New Orleans	Louisiana	United States	70121
34	Maine Center for Cancer Medicine and Blood Disorders	Scarborough	Maine	United States	04074
35	Methodist Cancer Center-Oncology Research	Omaha	Nebraska	United States	68114
36	Comprehensive Cancer Centers of Nevada (TORI)	Las Vegas	Nevada	United States	89109
37	Summit Medical Group Overlook Oncology Center	Summit	New Jersey	United States	07901
38	Cancer Research of Long Island	Great Neck	New York	United States	11023
39	Northwestern Carolina Oncology and Hematology	Hickory	North Carolina	United States	28603
40	Mid Dakota Clinic	Bismarck	North Dakota	United States	58501
41	Earle A. Chiles Research Institute	Portland	Oregon	United States	97213
42	Kaiser Permanente Northwest Region	Portland	Oregon	United States	97227
43	Univ. of Pittsburgh Cancer Center Inst.	Pittsburgh	Pennsylvania	United States	15232
44	University of Tenn. Cancer Ins	Memphis	Tennessee	United States	38104
45	The West Cancer Clinic	Memphis	Tennessee	United States	38120
46	M.D. Anderson	Houston	Texas	United States	77030
47	Virginia Mason Medical Center	Seattle	Washington	United States	98101
48	Internal Medicine Associates of Yakima	Yakima	Washington	United States	98902