Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC

• Register: ClinicalTrials.gov
• Last refreshed on: 17 December 2012
• Main ID: NCT00960297
• Date of registration: 13/08/2009
• Primary sponsor: Sarah Cannon Research Institute
• Public title: Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC
• Scientific title: Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III Non-Small Cell Lung Cancer
• Date of first enrolment: August 2009
• Target sample size: 75
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00960297
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David R Spigel, M.D.
• Affiliation: Sarah Cannon Research Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age >=18 years.

2. Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated).
Patients with squamous histology are not eligible.

3. Life expectancy of at least 12 weeks.

4. Patients with the following stages of NSCLC:

- T2 N0 tumors: Limited to tumors >=4 cm.

- T1-2 N1 tumors.

- T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving
the chest wall, proximal airway, or mediastinal pleura where preoperative RT is
not planned.

- T1-2 N2 tumors: For patients with N2 disease involving 1 zone (Upper zone (R),
AP zone (L), subcarinal zone, or lower zone) and nodes <=2 cm in diameter.

- T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions, other than
malignant effusions where radiotherapy is not planned.

5. Patients with clinical N2 involvement must have histologic confirmation by
mediastinoscopy (or alternate biopsy procedure).

6. Tumors should be considered potentially resectable.

7. No evidence of extrathoracic metastatic disease.

8. Patients must have measurable disease by RECIST version 1.1 criteria.

9. Patients must be candidates (medically) for chemotherapy followed by surgical
resection.

10. Adequate recovery from recent surgery. At least 1 week must have elapsed from the
time of a minor surgery (with the exception of portacath or other central access
catheter placement); at least 4 weeks must have elapsed from the time of a major
surgery.

11. Laboratory values as follows:

- Absolute neutrophil count (ANC) >=1500/µL

- Hemoglobin (Hgb) >=9 g/dL

- Platelets >=100,000/uL

- AST/SGOT and ALT/SGPT within normal limits (WNL)

- Total bilirubin within normal limits (WNL)

- Creatinine <=1.5 mg/dL

12. ECOG Performance Status grade 0 or 1.

13. Women of childbearing potential must have a negative serum or urine pregnancy test
performed within 7 days prior to start of treatment. Women of childbearing potential
or men with partners of childbearing potential must use effective birth control
measures during treatment. If a woman becomes pregnant or suspects she is pregnant
while participating in this study, she must agree to inform her treating physician
immediately.

14. Patient must be accessible for treatment and follow-up.

15. Patients must be able to understand the investigational nature of this study and give
written informed consent prior to study entry.

Exclusion Criteria:

1. Mixed small-cell and non-small cell histologies.

2. Pulmonary carcinoid tumors.

3. History of prior malignancy within 3 years, with the exception of non-melanoma skin
cancer or carcinoma in situ.

4. Peripheral neuropathy >= grade 1.

5. Patients receiving thrombolytic therapy within 10 days of starting study treatment
are ineligible. Therapeutic anticoagulation is allowed if the anticoagulant dosing is
stable.

6. History of acute myocardial infarction or unstable angina within 6 months prior to
Day 1 of study treatment.

7. History of or stroke or ischemic attack within 6 months prior to Day 1 of study
treatment.

8. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg
and/or diastolic blood pressure >100 mmHg) in spite of medical management.

9. New York Heart Association (NYHA) class II or greater congestive heart failure (CHF).

10. Patients with significant vascular disease (e.g., aortic aneurysm requiring surgical
repair, or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of
study treatment.

11. Any prior history of hypertensive crisis or hypertensive encephalopathy.

12. Patients with hematemesis or hemoptysis (>=1/2 teaspoon of bright red blood per
episode) within 1 month prior to Day 1 of study treatment.

13. Proteinuria at screening, as demonstrated by either:

- Urine protein: creatinine (UPC) ratio >=1.0 (see Appendix A) at screening, or

- Urine dipstick for proteinuria >=2+ (patients discovered to have >=2+
proteinuria on dipstick analysis should undergo a 24-hour urine collection and
must have <=1g of protein in 24 hours to be eligible).

14. Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.

15. Patients with evidence of bleeding diathesis or coagulopathy (in the absence of
therapeutic anticoagulation).

16. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 1 of study treatment.

17. Women who are pregnant (positive pregnancy test) or lactating.

18. Use of any non-approved or investigational agent within 28 days of administration of
the first dose of study drug.

19. Patients may not receive any other investigational or anti-cancer treatments while
participating in this study.

20. Concurrent severe, intercurrent illness including, but not limited to, ongoing or
active infection, or psychiatric illness/social situations that would limit
compliance with study requirements.

21. History of hypersensitivity to active or inactive excipients of any component of
treatment.

22. Inability to comply with study and/or follow-up procedures.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Bevacizumab

Drug: Carboplatin

Drug: Paclitaxel

Primary Outcome(s)

To assess 3-year overall survival in patients with stage IB (>4.0 cm), II, or select stage III NSCLC treated with preoperative carboplatin, paclitaxel, and bevacizumab followed by surgical resection. [Time Frame: 60 months]

Secondary Outcome(s)

To assess clinical & pathologic response rate, complete resection rate, toxicity, progression-free survival, & overall survival. [Time Frame: 60 months]

Secondary ID(s)

SCRI LUN 144

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech