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COMPLETEDPHASE1/PHASE2

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

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

NCT00043823•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

Primary Objectives: 1. (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). 2. (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: 1. (Phase I and II) To evaluate the pharmacokinetic interaction between the combination. 2. (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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+8 more criteria

Locations (2)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

August 1, 2002

Primary Completion Date

May 15, 2006

Completion Date

May 15, 2006

Last Updated

November 7, 2018

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

Avastin

DRUG

Tarceva

DRUG

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

NCT05198830

Lung AdenocarcinomaLung Large Cell Carcinoma+2 more

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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