Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

S

St. John Providence Health System

Status and phase

Unknown
Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: gemcitabine
Drug: bevacizumab
Drug: carboplatin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00150657
AVF3121s

Details and patient eligibility

About

this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen) all patients receive all three drugs; there is no placebo

Full description

Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible. Patients with brain metastases, squamous histology, or hemoptysis are excluded. All patients must give informed consent. Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy
  • Stage IV disease or stage IIIB with a malignant pleural effusion
  • measurable or evaluable disease
  • Performance status 0 or 1 (ECOG)
  • adequate renal, hepatic, and bone marrow function
  • adequate recovery from previous surgery or radiotherapy
  • informed consent

Exclusion criteria

  • brain metastases
  • squamous (epidermoid) histology
  • hemoptysis
  • central airway disease
  • Pancoast tumors
  • previous chemotherapy or biologic therapy for lung cancer
  • prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS
  • pregnant or nursing women

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Michael J Kraut, MD; Jaswinder Grewal, PhD

Data sourced from clinicaltrials.gov

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