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Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer



- Determine the median time to disease progression in patients with stage IIIB or IV or
recurrent non-squamous cell non-small cell lung cancer treated with carboplatin,
pemetrexed disodium, and bevacizumab.


- Determine the response rate and duration of response in patients treated with this

- Determine the toxic effects of this regimen in these patients.

- Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and
bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in
the absence of disease progression or unacceptable toxicity. After completion of 6 courses,
patients with complete response, partial response, or stable disease continue to receive
pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


- Histologically* or cytologically* confirmed non-small cell lung cancer

- Any histology, except squamous cell carcinoma, allowed

- Mixed tumors will be categorized by the predominant cell type unless small
cell elements are present, in which case the patient is ineligible

- No histology in close proximity to a major vessel or cavitation NOTE:
*Histologic or cytologic elements may be established on metastatic tumor
aspirates or biopsy

- Meets 1 of the following stage criteria:

- Stage IIIB disease (with malignant pleural effusion)

- Stage IV disease

- Recurrent disease

- Measurable or non-measurable disease

- No known CNS metastases by CT scan or MRI



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- No history of hemorrhagic disorders


- Bilirubin < 1.5 mg/dL

- AST and ALT < 5 times upper limit of normal

- INR < 1.5

- PTT normal


- Creatinine clearance ≥ 45 mL/min

- Urine protein:creatinine ≤ 1.0 by spot urinalysis


- No myocardial infarction within the past 6 months

- No New York Heart Association class II-IV congestive heart failure

- No unstable angina pectoris

- No serious cardiac arrhythmia requiring medication

- No stroke within the past 6 months

- No peripheral vascular disease ≥ grade 2

- No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg)

- Patients with a history of hypertension allowed provided blood pressure is well
controlled on a stable regimen of anti-hypertensive therapy

- No history of thrombotic disorders

- No other clinically significant cardiovascular disease


- No history of gross hemoptysis, defined as bright red blood of a ½ teaspoon or more


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be willing and able to take daily oral folic acid, intermittent vitamin B_12
injections, and corticosteroid premedication

- No ongoing or active infection

- No serious, non-healing wound, ulcer, or bone fracture

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

- More than 3 weeks since prior immunotherapy


- No prior systemic chemotherapy

Endocrine therapy

- More than 3 weeks since prior hormonal therapy


- See Disease Characteristics

- More than 3 weeks since prior radiotherapy


- More than 4 weeks since prior major surgery

- More than 1 week since prior minor surgery, fine needle aspiration, or core biopsy

- No concurrent major surgery


- Recovered from all prior therapy

- More than 4 weeks since prior and no concurrent participation in another experimental
drug study

- No aspirin or other nonsteroidal anti-inflammatory drug (NSAID) 2 days before and 2
days after each pemetrexed disodium infusion (5 days before and 2 days after each
pemetrexed disodium infusion for NSAIDs with a long half-life [e.g., naproxen,
rofecoxib, or celecoxib])

- No concurrent therapeutic anticoagulation

- Concurrent prophylactic anticoagulation for venous access devices allowed
provided requirements for INR and PTT are met

- No concurrent administration of any of the following:

- Chronic daily treatment with aspirin (> 325 mg per day)

- NSAIDs known to inhibit platelet function, including any of the following:

- Dipyridamole

- Ticlopidine

- Clopidogrel

- Cilostazol

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:

Median time to progression

Outcome Time Frame:

Approximately every 3 weeks until disease progression

Safety Issue:


Principal Investigator

Jyoti D. Patel

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 04L2



Start Date:

June 2005

Completion Date:

May 2015

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Evanston Northwestern Healthcare - Evanston Hospital Evanston, Illinois  60201-1781
Advocate Lutheran General Cancer Care Center Park Ridge, Illinois  60068-1174
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey, Illinois  60426
Rush Cancer Institute at Rush University Medical Center Chicago, Illinois  60612