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A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage
IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab,
docetaxel, and gemcitabine hydrochloride.

Secondary

- Evaluate the median time to progression in patients treated with this regimen.

- Estimate the response rate in patients treated with this regimen.

- Determine the median overall survival of patients treated with this regimen.

- Determine the incidence of adverse events associated with this regimen in these
patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes
on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats
every 21 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients with responsive or stable disease may then continue to receive
bevacizumab alone for up to 12 months in the absence of disease progression.

After completion of study treatment, patients are followed up every 3 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed non-squamous cell non-small cell lung cancer

- Stage IIIB (with pleural effusion), stage IV, or recurrent disease

- Bidimensionally measurable disease

- No known CNS disease, except for previously treated brain metastasis defined as no
evidence of progression or hemorrhage after treatment AND no ongoing requirement for
dexamethasone as documented by clinical examination, MRI, or CT scan

- Treatment for brain metastases may have included whole brain radiotherapy,
radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as
deemed appropriate by the treating physician

- Stable dose of anticonvulsants allowed

- No known metastatic disease to the gastrointestinal tract (e.g., stomach, small
bowel, or large bowel)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy > 3 months

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Bilirubin ≤ 2.0 mg/dL

- AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic
metastases are present)

- Serum creatinine ≤ 1.8 mg/dL

- Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR ≤ 1 g
of protein by 24-hour urine collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Available for regular follow-ups

- No inadequately controlled hypertension, defined as systolic BP > 150 mm Hg and/or
diastolic BP > 100 mm Hg despite antihypertensive medications

- No history of hypertensive crisis or hypertensive encephalopathy

- No NYHA class II-IV congestive heart failure

- No myocardial infarction or unstable angina within the past 6 months

- No stroke or transient ischemic attack within the past 6 months

- No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring
surgical repair, or recent peripheral arterial thrombosis) within the past 6 months

- No symptomatic peripheral vascular disease

- No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic
anticoagulation)

- No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No serious, nonhealing wound, ulcer, or bone fracture

- No known hypersensitivity to any component of bevacizumab

- No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months

- No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or biological therapy

- No prior radiotherapy to an area of measurable disease unless there is documented
progressive disease after completion of therapy

- More than 2 weeks since prior radiotherapy

- More than 4 weeks since prior and no concurrent participation in another experimental
drug study, except for a Genentech-sponsored bevacizumab cancer study

- More than 28 days since prior major surgical procedure or open biopsy

- More than 3 months since prior abdominal surgery

- More than 3 months since prior neurosurgical resection or brain biopsy

- More than 7 days since prior core biopsy or other minor surgical procedure, except
placement of a vascular access device

- No concurrent major surgical procedure

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Description:

Progression free survival

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Nathan Pennell, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE4507

NCT ID:

NCT00970684

Start Date:

September 2009

Completion Date:

November 2013

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195
Fairview Hospital, Moll PavilionCleveland, Ohio  44111
Hillcrest Hospital, a Cleveland Clinic HospitalMayfield Heights, Ohio  44124