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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00436332
First received: February 15, 2007
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: erlotinib hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From date of registration to maximum of 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From date of registration to maximum of 3 years ] [ Designated as safety issue: No ]
  • Response as assessed by RECIST criteria vs central computer-assisted image-analysis system in patients with measurable disease [ Time Frame: From date of registration to maximum of 3 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: From date of registration to maximum of 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: July 2007
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib and Bevacizumab Biological: bevacizumab Drug: erlotinib hydrochloride

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436332

  Show 148 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Howard L. West, MD Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00436332     History of Changes
Other Study ID Numbers: CDR0000529756, S0635, U10CA032102
Study First Received: February 15, 2007
Last Updated: February 12, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
bronchoalveolar cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Adenocarcinoma
Carcinoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014