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Status:

COMPLETED

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

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

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. So...

Detailed Description

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 bev...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 20 2019

    Estimated Enrollment :

    84 Patients enrolled

    Trial Details

    Trial ID

    NCT00436332

    Start Date

    July 1 2007

    End Date

    August 20 2019

    Last Update

    April 2 2020

    Active Locations (148)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 37 (148 locations)

    1

    Kaiser Permanente - Deer Valley

    Antioch, California, United States, 94531

    2

    Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, United States, 94704

    3

    Peninsula Medical Center

    Burlingame, California, United States, 94010

    4

    Kaiser Permanente - Fremont

    Fremont, California, United States, 94538