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Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients

This study is currently recruiting patients.

Sponsored by

M.D. Anderson Cancer Center

Genentech

Vanderbilt-Ingram Cancer Center

Purpose

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.

MEDLINEplus related topics:  Cancer (General);   Cancer Alternative Therapy;  

Cancer--Living with Cancer;   Lung Cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

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

Eligibility

Genders Eligible for Study:  Both

Criteria

Inclusion:

·         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 (SGOT and/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:

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

·         Patient has received prior biologic therapy targeting EGFR and/or 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 CNS malignancy or with recently treated CNS malignancy, as well as those experiencing recent 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 PEG or G tube.

Expected Total Enrollment:  48

Location and Contact Information

Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232,  United States; Not yet recruiting

Peggy Krozely, RN  615-936-5795  Peggy.krozely@mcmail.vanderbilt.edu  Julie Ozier, CCRC  615-936-5874  Julie.Ozier@mcmail.vanderbilt.edu  Alan Sandler, MD,  Sub-Investigator

Texas
      University of Texas M.D. Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting

Ted Henderson, RN  713-745-6762  thenders@mdanderson.org  Jeanne Riddle, RN  713-745-6753  jriddle@mdanderson.org  Roy S Herbst, MD, PhD,  Principal Investigator

More Information

Study ID Numbers  ID01-604;  VICC THO 0206
Study Start Date August 2002
Record last reviewed  February 2003
NLM Identifier  NCT00043823
ClinicalTrials.gov processed this record on 2003-05-30

Source: clinicaltrials.gov

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