Know Cancer

forgot password

Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated

Phase 1/Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated

Patients will be treated with oral Tarceva daily for 21 days each cycle. Patients will
receive Avastin by IV on day 1 of each 21-day cycle. If a patient has no grade 3 or 4
toxicities after the 1st cycle, then the patient may continue the same doses of Tarceva and
Avastin for another cycle. If the patient has response or stable disease after 6 weeks (2
cycles), the patient may continue on the same doses of Tarceva and Avastin. A patient may
receive treatment on this study for up to one year, unless his or her disease progresses or
side effects become too severe.

The starting dose is 100 mg daily of Tarceva and 7.5 mg/kg every 21 days of Avastin.

Inclusion Criteria:

- Patient has histologically proven stage IIIB with pleural effusion, stage IV or
recurrent non-squamous NSCLC.

- Patient has a Karnofsky performance status >=70%.

- Patient has adequate bone marrow function: WBC >= 3,000 cells/mm3, ANC >= 1,500
cells/mm3, platelet count >= 100,000 cells/mm3, Hgb >= 9.0 g/dL.

- Patient has adequate liver function: total bilirubin level <= 2.0 mg/dL, albumin >=
2.5 g/dL.

- Transaminases (aspartate aminotransferase (AST or SGOT) and/or alanine
aminotransferase (ALT or SGPT)) and alkaline phosphatase may be up to 2.5 x ULN.

- Patient has adequate renal function: a serum creatinine < 2 mg/dl

- Patient has signed a written informed consent.

- Patient has received at least one prior chemotherapeutic regimen for recurrent or
metastatic disease.

Exclusion Criteria:

- Patient has not received prior chemotherapeutic regimens for advanced disease.

- Patient has received prior biologic therapy targeting epidermal growth factor
receptor (EGFR) and/or Vascular endothelial growth factor (VEGF).

- Patient has received radiation therapy within the past 3 weeks.

- Patient has signs or symptoms of acute infection requiring systemic therapy.

- Patient exhibits confusion, disorientation, or has a history of major psychiatric
illness that may impair patient's understanding of the informed consent.

- Patient requires total parenteral nutrition with lipids.

- Patient has a history of uncontrolled heart disease and/or uncontrolled hypertension
(> 150/100 mmHg).

- Because of the possible teratogenic effect, pregnant women and women who are
currently breast-feeding may not participate in this study. - All women of
childbearing potential must have a negative pregnancy test within 24 hours prior to
enrolling in the study.

- Serious infection or other intercurrent illness requiring immediate therapy.

- Clinical/imaging evidence of Central Nervous System (CNS) malignancy or with recently
treated CNS malignancy, as well as those experiencing recent cerebrovascular accident
(CVA), or other CNS bleeding.

- Pediatric patients in whom open growth plates would be expected.

- Urine protein qualitative value of > 30 in urinalysis or > +1 in proteinuria testing
by dipstick.

- Patient has a clinical history of coagulopathy or thrombosis.

- Patient is currently receiving or intending to receive anti-coagulants.

- Patient has had a recent myocardial infarction (still inside the healing period).
Note: a six-month window is optimal.

- Patient is recovering from recent major surgery (e.g., less than 2 weeks since
surgery) or is anticipating major surgery.

- Patient has a clinical history of hemoptysis or hematemesis.

- Patient may not have percutaneous endoscopic gastrostomy (PEG) or gastrostomy (G)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin

Outcome Time Frame:

After each 21 day cycle

Safety Issue:


Principal Investigator

Roy S. Herbst, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2002

Completion Date:

May 2006

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Avastin
  • Bevacizumab
  • rhuMAb VEGF
  • Anti-VEGF monoclonal antibody
  • Tarceva
  • OSI-774
  • Erlotinib Hydrocholoride
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
University of Texas M.D. Anderson Cancer Center Houston, Texas  77030