Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI UCCRC-12653A NCI-2655, OSU-0120, NCT00025389, 2655

Objectives

1. Determine the clinical complete and partial response rate in patients with stage IB, II, or IIIA resectable non-small cell lung cancer treated with neoadjuvant bevacizumab, paclitaxel, and carboplatin.
2. Determine the pathologic complete response rate in patients treated with this regimen.
3. Determine the ability to proceed with and complete a potentially curative resection in patients treated with this regimen.
4. Determine the safety and toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed non-small cell lung cancer
  • Stage IB (T2, N0), II (T1 or T2, N1 or T3, N0), or IIIA (T3, N1)
  • Potentially resectable disease



• No large central primary tumors in proximity to significant blood vessels



• No bronchoscopically evident endobronchial tumors



• At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No prior biologic therapy for this cancer
• No concurrent prophylactic growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF])

Chemotherapy:

• No prior chemotherapy for this cancer
• Prior chemotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled

Endocrine therapy:

• No prior endocrine therapy for this cancer

Radiotherapy:

• No prior radiotherapy for this cancer
• Prior radiotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled
• No concurrent radiotherapy

Surgery:

• Prior diagnostic bronchoscopy, mediastinoscopy, or CT-guided biopsy allowed
• At least 28 days since prior major surgical procedure or open biopsy

Other:

• No other concurrent investigational agents
• No other concurrent anticancer investigational or commercial agents or therapies
• No concurrent combination antiretroviral therapy for HIV-positive patients
• Concurrent low-dose warfarin for maintenence of preexisting, permanent, indwelling IV catheters allowed provided INR less than 1.5

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

  OR

• Karnofsky 70-100%

Life expectancy:

• More than 12 months

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• No history of an inherited bleeding disorder
• No inherited predisposition to a hypercoagulable state
• No clinically evident hypercoagulable state or bleeding diathesis

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 2.5 times ULN
• INR less than 1.5
• PTT less than 36 seconds

Renal:

• Creatinine less than 1.5 times ULN

  OR

• Creatinine clearance at least 60 mL/min
• No nephrotic syndrome
• Urine protein no greater than 0.5 g/24 hours

Cardiovascular:

• No poorly controlled hypertension (greater than 150 mm Hg systolic and/or greater than 100 mm Hg diastolic) despite treatment
• No uncompensated coronary artery disease
• No myocardial infarction within the past 6 months
• No clinically significant or severe peripheral vascular disease
• No inherited predisposition to thrombosis
• No deep venous or arterial thrombosis
• No symptomatic congestive heart failure
• No unstable angina pectoris within the past 6 months
• No cardiac arrhythmia
• No transient ischemic attack within the past 6 months
• No cerebrovascular accident within the past 6 months
• No other arterial thromboembolic event within the past 6 months

Pulmonary:

• No hemoptysis
• No pulmonary embolism

Other:

• No history of allergic reactions to compounds of similar chemical or biologic composition to study drugs
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No psychiatric illness or social situation that would preclude study compliance
• No significant traumatic injury within the past 28 days
• No uncontrolled concurrent illness
• No ongoing or active infection
• No serious, non-healing wound, ulcer, or bone fracture
• No other active malignancy
• No requirement for full-dose anticoagulation or thrombolytic therapy

Expected Enrollment

A total of 23-39 patients will be accrued for this study.

Outline

Patients receive neoadjuvant bevacizumab IV over 60-90 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1.

Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy.

Patients are followed within 3 months.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Ann Mauer, MD, Protocol chair		Ph: 773-702-4138; 888-824-0200

Registry Information
Official Title		A Phase 2 Study Of Neoadjuvant rhuMAb VEGF (bevacizumab) In Combination With Paclitaxel And Carboplatin In Surgically Resectable Non-Small Cell Lung Cancer
Trial Start Date		2001-11-09
Registered in ClinicalTrials.gov		NCT00025389
Date Submitted to PDQ		2001-08-13
Information Last Verified		2005-03-10
NCI Grant/Contract Number		P30-CA16058

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