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Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced (Stage IIIB(With Malignant Pleural Effusion) or IV) Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Phase 1/Phase 2
70 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced (Stage IIIB(With Malignant Pleural Effusion) or IV) Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This is a Phase I/II trial of elderly patients (> 70 years of age) with previously
un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural
effusion) and stage IV disease will be enrolled.

Treatment Regimen:

Premetrexed (Alimta™) 500 milligrams(mg)/Meter squared(m20 Intravenous(I.V.) Day 1 and Day
15; Bevacizumab 10mg/Kilogram(Kg) I. V. Day 1 and Day 15; Erlotinib (Tarceva™) 150mg Per
Orally(PO) Once Daily(QD) for 7 days starting day 2 and day 15; Repeat cycles every 28 days.

All three drugs will be continued for two cycles after maximal response. After which patient
will be maintained only on the Bevacizumab and Erlotinib until progression. If patient has
stable disease after the first two cycles then patient will be given another two cycles with
all three drugs before maintenance treatment with Bevacizumab and Erlotinib is initiated.

Inclusion Criteria:

- Patient must have histologically proven diagnosis of Non-Squamous NSCLC. NSCLC
histologies that will be included in this trial will be adenocarcinoma, large cell
carcinoma and adeno-squamous carcinoma. Patients with bronchioloalveolar carcinoma
(BAC) will be also included in this trial.

- Patients must be 70 years of age or older.

- Patient must have either stage IIIB disease with malignant pleural effusion or stage
IV disease. All patients must have measurable disease. Evaluable disease will be
separately outlined and elucidated.

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of
either 0 or 1.

- Patient must have adequate renal function with a serum creatinine level of less than
1.5mg/dl and patient should have a calculated creatinine clearance of more than

- Patient must have adequate hepatic function with a serum bilirubin level of less that
3mg/dl, and an alkaline phosphatase, Alanine Amino Transferase (ALT) and Aspartate
Amino Transferase (AST) of less than three times the upper limit of normal

- Patient must also have evidence of adequate bone marrow function with an absolute
neutrophil count of more than 1, 500 cells per deciliter and a platelet count of more
than 100,000 per deciliter.

- Patients must be more than 28 days since prior open biopsy; more than 7 days since
prior fine-needle aspiration; more than 7 days since prior core biopsy; more than 28
days since prior surgery.

- Patients must be able to take dexamethasone, folic acid and vitamin B-12

- All patients must sign informed consent that will detail the investigational nature
of the study in accordance with the institutional and federal guidelines.

Exclusion Criteria:

- Lung carcinoma of squamous cell histology or any histology in close proximity to a
major vessel, with or without cavitation.

- Patients with hypercalcemia (corrected calcium of more than 11 mg/dl) will be

- Patients with history of hemoptysis, hematemesis, coagulopathy or thrombosis will be

- Patients requiring anticoagulation for any reason will be excluded.

- Patients who recently have an acute infection.

- History of palliative radiation therapy within 2 weeks.

- Blood pressure of >150/100 Millimeter Mercury(mmHg).

- Currently ongoing unstable angina.

- New York Heart Association (NYHA) Grade II or greater congestive heart failure.

- History of myocardial infarction within 6 months.

- History of stroke within 6 months.

- Clinically significant peripheral vascular disease.

- Presence of central nervous system or brain metastases.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course
of the study.

- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to Day 0.

- Pregnant (positive pregnancy test) or lactating.

- Urine calculated creatinine clearance of less than 45ml/minute and a urinary protein.
Creatinine ratio of more than 1.

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 1.

- Serious, non-healing wound, ulcer, or bone fracture.

- Inability to comply with study and/or follow-up procedures.

Type of Study:


Study Design:

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

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

The primary objective was to determine the progression free survival (PFS), in newly diagnosed patients with advanced Non Small Cell Lung Cancer (NSCLC) who are treated with a regimen consisting of Bevacizumab(B), pemetrexed(A), and erlotnib(T). This was a Phase I/II study. This trial was halted after the Phase I component was completed. The Phase II component was never initiated.

Outcome Time Frame:

26 months

Safety Issue:


Principal Investigator

George Simon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

September 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion, Malignant



H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612