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Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Avastin
Tarceva
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, Lung Cancer, Avastin, Bevacizumab, rhuMAb VEGF, Anti-VEGF monoclonal antibody, Tarceva, OSI-774, Erlotinib Hydrocholoride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) tube.

Sites / Locations

  • Vanderbilt-Ingram Cancer Center
  • University of Texas M.D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avastin + Tarceva

Arm Description

Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response in Patients With NSCLC Receiving Combination Avastin and Tarceva

Full Information

First Posted
August 14, 2002
Last Updated
November 5, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Genentech, Inc., Vanderbilt-Ingram Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00043823
Brief Title
Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2002 (Actual)
Primary Completion Date
May 15, 2006 (Actual)
Study Completion Date
May 15, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Genentech, Inc., Vanderbilt-Ingram Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objectives: (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC). (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study. Secondary Objectives: (Phase I and II) To evaluate the pharmacokinetic interaction between the combination. (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Non-Small Cell Lung Cancer, NSCLC, Lung Cancer, Avastin, Bevacizumab, rhuMAb VEGF, Anti-VEGF monoclonal antibody, Tarceva, OSI-774, Erlotinib Hydrocholoride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avastin + Tarceva
Arm Type
Experimental
Arm Description
Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
rhuMAb VEGF, Bevacizumab, Anti-VEGF monoclonal antibody
Intervention Description
7.5 mg/kg By Vein on Day 1 of Every 21 Day Cycle
Intervention Type
Drug
Intervention Name(s)
Tarceva
Other Intervention Name(s)
OSI-774, Erlotinib Hydrocholoride
Intervention Description
100 mg By Mouth Daily for 3 Weeks
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin
Time Frame
After each 21 day cycle
Secondary Outcome Measure Information:
Title
Response in Patients With NSCLC Receiving Combination Avastin and Tarceva
Time Frame
6 weeks (2 cycles)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) tube.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy S. Herbst, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer

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