Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

NCT01057212 | Terminated Phase 2

• 1 other identifier: 09-97B
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, open-label, single arm phase II trial of the combination of bevacizumab and ixabepilone in patients with advanced- or metastatic non-squamous NSCLC progressive after first or second-line therapy. The main objective is to evaluate the progression-free survival in patients with advanced or metastatic non-squamous NSCLC being treated with ixabepilone and bevacizumab.

Conditions

Non-squamous Non-small Cell Lung Cancer

Keywords

advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  at week 8, week 16, and every 8 weeks until disease progression or removal from study

Secondary Outcomes (2)

• To evaluate the overall response rate using RECIST criteria

  at week 8, week 16, and every 8 weeks until disease progression or removal from study

• toxicities associated with treatment combination in advanced non-squamous NSCLC

  all treatment days and every 2 months post-treatment

Study Arms (1)

Bevacizumab and Ixabepilone

EXPERIMENTAL

Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks. Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule to the remaining 40 patients.

Drug: ixabepilone; Drug: bevacizumab

Interventions

ixabepilone DRUG

Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the remaining 40 patients enrolled.

Also known as: IXEMPRA®

Bevacizumab and Ixabepilone

bevacizumab DRUG

Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks.

Also known as: Avastin

Bevacizumab and Ixabepilone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC), excluding squamous cell-predominant subtype. NSCLC NOS (not otherwise specified) are eligible.
• Patients must have had at least one but no more than two prior systemic chemotherapeutic regimens for metastatic disease. Prior neoadjuvant or adjuvant chemotherapy will not be included in the assessment as a prior chemotherapeutic regimen. Prior therapy with taxanes is allowed. Prior therapy with bevacizumab is allowed.
• Prior chemotherapy or therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
• Zubrod performance status of 0 or 1.
• Patients must have measurable or evaluable disease as defined by RECIST.
• Treated brain metastases will be allowed, provided they are asymptomatic. Radiation treatment for brain metastasis must have been completed at least 2 weeks prior to enrollment. Patients must demonstrate stable symptoms and seizure control on a consistent dose of anticonvulsants for at least 2 weeks prior to enrollment. Patients must be off corticosteroids for at least 2 weeks. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, KINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
• Radiation for symptomatic lesions outside the CNS must have been completed at least 2 weeks prior to study enrollment. If measurable disease is within the radiation field, there must be evidence of clear progression (using RECIST criteria) at the time of study enrollment.
• Major surgical procedures must have been performed \>28 days prior to study treatment. Portacath placement must have been performed \>14 days prior to study treatment. Minor surgical procedures (fine needle aspiration, core biopsy, or mediastinoscopy) must have been performed \>7 days prior to study treatment.
• Patients must have normal organ and marrow function as defined below:
• leukocytes \> 3,000/uL
• absolute neutrophil count \> 1,500/uL
• platelets \> 100,000/uL
• total bilirubin within normal institutional limits
• AST (SGOT)/ALT (SGPT) \< 2.5 X institutional upper limit of normal
• creatinine \< 1.5 mg/dL, OR

You may not qualify if:

• NSCLC with predominant squamous cell histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable).
• History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 1 month prior to Day 1.
• Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone (within the last two weeks prior to Day 1), as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
• Inability to comply with study and/or follow-up procedures.
• An investigational agent within 3 weeks of Day 1.
• Patients with greater than grade 1 neuropathy.
• Pregnant (positive pregnancy test) or lactating.
• Serious concomitant medical disorder, including active infection.
• Active second primary malignancy at the time of study enrollment.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixabepilone or Cremophor EL (polyoxyethylated castor oil).
• History of co-existing psychiatric illness that could impair compliance with study protocol.
• Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications).
• Any prior history of hypertensive crisis or hypertensive encephalopathy.
• New York Heart Association (NYHA) Grade II or greater congestive heart failure.
• History of myocardial infarction or unstable angina within 6 months prior to Day 1.

Sponsors & Collaborators

• Providence Health & Services: lead
• Genentech, Inc.: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Interventions

ixabepilone; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rachel Sanborn, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 27, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

US (1)