Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Nathan Pennell, MD, PhD

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: gemcitabine hydrochloride

Biological: bevacizumab

Drug: docetaxel

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00970684

CASE4507 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

NCI-2010-00547 (Other Identifier)

CASE 4507-CC694 (Other Identifier)

Details and patient eligibility

About

RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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