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Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer


- 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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to progression

Principal Investigator

Michael J Kraut, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Providence Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

AVF3121s

NCT ID:

NCT00150657

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Providence Cancer InstituteSouthfield, Michigan  48075