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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00095225
First received: November 1, 2004
Last updated: January 23, 2008
Last verified: January 2008
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

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.

Enrollment: 122
Study Start Date: July 2004
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (> 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) &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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095225

  Show 48 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Vince O'Neill, M.D. Genentech
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00095225     History of Changes
Obsolete Identifiers: NCT00098410
Other Study ID Numbers: OSI2950g
Study First Received: November 1, 2004
Last Updated: January 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Recurrent or refractory non-small cell lung cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Recurrence, Local
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Disease Attributes
Bevacizumab
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014