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A Phase II Study Evaluating a Maintenance Strategy of Gleevce® (Imatinib Mesylate) and Bevacizumab in Patients With Advanced, Non-squamous, Non-small Cell Lung Cancer, Following Completion of First-line Chemotherapy With Bevacizumab


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Study Evaluating a Maintenance Strategy of Gleevce® (Imatinib Mesylate) and Bevacizumab in Patients With Advanced, Non-squamous, Non-small Cell Lung Cancer, Following Completion of First-line Chemotherapy With Bevacizumab


OBJECTIVES:

Primary

- Determine the clinical efficacy of maintenance therapy comprising imatinib mesylate and
bevacizumab after completion of first-line, platinum-based chemotherapy and
bevacizumab, in terms of progression-free survival, in patients with stage IIIB or IV
non-small cell lung cancer.

Secondary

- Assess the safety profile of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral imatinib mesylate twice daily on days 1-21 and bevacizumab IV over 30
minutes on day 1. Treatment repeats every 21 days for 1 year in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer

- Stage IIIB (by pleural effusion only) or stage IV disease

- No predominately squamous cell carcinoma

- Mixed tumors will be categorized by predominant cell type

- Must have completed 4 courses of platinum-based, doublet chemotherapy and
bevacizumab*, has no disease progression, and meets the following criteria:

- Platinum agent may have included carboplatin or cisplatin

- Second agent may have included paclitaxel, docetaxel, gemcitabine hydrochloride,
vinorelbine ditartrate, or pemetrexed disodium

- A change in the platinum doublet is acceptable provided the following are true:

- Basis for change was toxicity rather than disease progression

- Total number of courses of any platinum doublet plus bevacizumab was 4

- At least 3 of 4 courses must have included bevacizumab NOTE: *Patients age 70
and over may have completed 4 courses of single-agent chemotherapy plus
bevacizumab; single agent chemotherapy may have included paclitaxel, docetaxel,
gemcitabine hydrochloride, vinorelbine ditartrate, or pemetrexed disodium

- No brain metastases by brain MRI or head CT scan

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Bilirubin ≤ 1.25 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Creatinine ≤ 1.5 times ULN

- Absolute neutrophil count ≥ 1500/mm³

- Platelet count ≥ 100,000/mm³

- INR ≤ 1.5 times ULN

- Urine protein:creatinine ratio ≤ 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 3 months
after completion of study treatment

- No history of gross hemoptysis (defined as > ½ teaspoon of bright red blood)

- No inadequately controlled hypertension (defined as blood pressure > 150/100 mm Hg on
antihypertensive medications)

- No significant traumatic injury within the past 28 days

- No condition requiring continuous administration of systemic corticosteroids

- No medical condition that would preclude study treatment

- No medical comorbidities, including any of the following:

- Unstable angina

- Congestive heart failure ≥ grade 2

- Myocardial infarction within the past 6 months

- Stroke within the past 6 months

- Peripheral vascular disease ≥ grade 2 within the past 6 months

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior systemic chemotherapy in the metastatic setting, except for 4 courses of
platinum-based, doublet chemotherapy plus bevacizumab in the first-line setting

- Prior adjuvant, neoadjuvant, or combined modality chemoradiation for localized
non-small cell lung cancer allowed provided ≥ 6 months elapsed before metastatic
recurrence

- At least 28 days since prior major surgical procedure

- No prior antiangiogenic drug, including AMG 706, CP-547, 632, vatalanib, AZD2171,
thalidomide, sorafenib tosylate, or sunitinib malate

- No other concurrent investigational drugs

- No concurrent grapefruit juice or products containing grapefruit

- No other concurrent anticancer agents, including chemotherapy and biological agents

- No concurrent major surgical procedure

- No concurrent therapeutic coagulation comprising warfarin, heparin, or low molecular
weight heparin

- Low-dose warfarin (e.g., 1 mg/day) for prophylaxis of central venous catheter
thrombosis allowed

- No chronic daily acetylsalicylic acid (> 325 mg/day) or other full-dose nonsteroidal
anti-inflammatory drug with antiplatelet activity

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Laurie Carr, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

6351

NCT ID:

NCT00425646

Start Date:

November 2006

Completion Date:

July 2009

Related Keywords:

  • 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
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Seattle Cancer Care AllianceSeattle, Washington  98109