S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:11/10/2018
Start Date:July 2007
End Date:August 2019

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A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in
different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop
the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with
bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab
works in treating patients with stage III or stage IV non-small cell lung cancer.

OBJECTIVES:

Primary

- Determine overall survival of patients with stage IIIB or IV bronchioloalveolar
carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride
and bevacizumab.

Secondary

- Determine the progression-free survival of patients treated with this regimen.

- Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed
by a central computer-assisted image-analysis system in patients with measurable disease
treated with this regimen.

- Assess the frequency and severity of toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over
30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression
or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then
every 6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Biopsy-proven* bronchioloalveolar carcinoma (BAC) or BAC variants (e.g.,
adenocarcinoma with BAC features, BAC with invasive adenocarcinoma) meeting the
following criteria:

- Incompletely resected or unresectable disease

- No component of squamous cell carcinoma

- Disease staged as 1 of the following:

- Stage IIIB disease (T4 [cytologically confirmed malignant pleural effusion
OR pleural tumor foci that are separate from direct pleural invasion by the
primary tumor], any N, M0)

- Stage IV disease (any T, any N, M1 [distant metastases present])

- Recurrent disease in a separate lobe after prior resection within the
past 5 years; multifocal lesions in > 1 lobe; or any disease that is
recurrent after surgery or radiotherapy is considered stage IV disease

- Tumor may be multifocal or diffuse NOTE: *Cytology specimens, including bronchial
brushing, washings, or fine needle aspiration specimens, alone are not acceptable
for diagnosis

- Measurable or nonmeasurable disease by chest CT scan

- Pleural effusions, ascites, and laboratory parameters are not acceptable as only
evidence of disease

- Disease must be present outside field of prior radiotherapy OR a new lesion must
be inside port

- Treated brain metastases allowed provided the patient is asymptomatic and do not
require steroids

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin normal

- AST or AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
are present)

- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases are present)

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1 g by 24-hour urine
collection

- Willing to provide prior smoking history

- No hemoptysis ≥ ½ teaspoon within the past 28 days

- No clinical history of pulmonary or upper respiratory hemorrhage > grade 2 within the
past 6 months or > grade 1 within the past 28 days

- No history of thromboses or hemorrhage, including hemorrhagic or thrombotic stroke, or
other CNS bleeding

- No uncontrolled hypertension

- No serious nonhealing wound, ulcer, or bone fracture

- No other prior malignancy except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer that is currently in complete remission

- Any other cancer from which the patient has been disease free for 5 years

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior therapy

- At least 28 days since prior radiotherapy (14 days for palliative radiotherapy)

- At least 28 days since prior surgery (thoracic or other major surgeries)

- More than 7 days since prior fine-needle aspiration or core biopsy

- At least 28 days since prior systemic chemotherapy or biologic therapy

- No prior gefitinib hydrochloride, erlotinib hydrochloride, or bevacizumab

- No other prior anti-epidermal growth factor receptor or anti-vascular endothelial
growth factor therapies

- Concurrent stable, therapeutic anticoagulation therapy allowed (i.e., warfarin or low
molecular weight heparin), provided the patient has no history of bleeding
complications on anticoagulation or an inability to establish a stable therapeutic
regimen for anticoagulation

- No other concurrent anticancer therapy, including surgery, chemotherapy, hormone
therapy, biologic therapy, or radiotherapy
We found this trial at
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86 Jonathan Lucas Street
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1 Hurley Plaza
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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2279 45th Street
Sacramento, California 95817
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1959 NE Pacific St
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