Vinorelbine and Bevacizumab in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
James P. Wilmot Cancer Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00309998
First received: March 29, 2006
Last updated: February 26, 2011
Last verified: December 2008
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Purpose
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving vinorelbine together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vinorelbine together with bevacizumab works in treating older patients with stage III or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: bevacizumab Drug: vinorelbine tartrate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Median time to disease progression by imaging study every 6 weeks [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate by imaging study every 6 weeks [ Designated as safety issue: No ]
- Median survival [ Designated as safety issue: No ]
- Safety as measured by toxicity (e.g thromboembolism, bleeding, or bowel perforation) every three weeks or as required [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Estimate the median time to disease progression in older patients with non-squamous stage IIIB or stage IV non-small cell lung cancer (NSCLC) treated with vinorelbine ditartate and bevacizumab.
Secondary
- Estimate the response rate in patients treated with this regimen.
- Estimate the median survival in patients treated with this regimen.
- Evaluate the safety of the combination of vinorelbine ditartate and bevacizumab in older patients.
OUTLINE: This is an open-label study.
Patients receive vinorelbine ditartate IV over 6 to 10 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-squamous, non-small cell lung cancer (NSCLC)
- Stage IIIB (any T, N3, M0 OR T4, any N, M0, OR pleural effusion) OR stage IV (any T, any N, M1) disease
- Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible
- Measurable or evaluable disease
- No lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel or cavitation
- No known brain metastases, even if treated
PATIENT CHARACTERISTICS:
- No other malignancies within the past 5 years except nonmelanoma skin cancer
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- Transaminases ≤ 5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Urine protein:creatinine ratio < 1
- INR ≤ 1.5
- PTT normal
- No prior ileus or neuropathy compromising use of vinorelbine ditartate
- Patients with a history of hypertension must be well controlled (blood pressure < 150/100 mm Hg) on a stable regimen of antihypertensive therapy
None of the following conditions:
- Unstable angina
- New York Heart Association grade II-IV congestive heart failure
- Myocardial infarction within the past 6 months
- Stroke within the past 6 months
- Evidence of bleeding diathesis or coagulopathy
- Clinically significant peripheral vascular disease
- Serious, nonhealing wound, ulcer, or bone fracture
- History of hemoptysis (bright red blood ≥ ½ teaspoon)
- No significant traumatic injury within the past 4 weeks
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for NSCLC
- More than 4 weeks since prior and no concurrent participation in another experimental drug study
- More than 4 weeks since prior immunotherapy, hormonal therapy, or radiotherapy and recovered
More than 28 days since prior major surgical procedure or open biopsy
- No anticipation of need for major surgery during course of trial
- More than 7 days since prior minor surgical procedures (e.g., fine-needle aspiration or core biopsy)
- No concurrent full-dose anticoagulation therapy for thromboembolic disease, aspirin (> 325 mg/day), or nonsteroidal anti-inflammatory drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309998
Locations
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642-0001 | |
Sponsors and Collaborators
James P. Wilmot Cancer Center
Investigators
| Study Chair: | Deepak M. Sahasrabudhe, MD | James P. Wilmot Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Deepak M. Sahasrabudhe, James P. Wilmot Cancer Center at University of Rochester Medical Center |
| ClinicalTrials.gov Identifier: | NCT00309998 History of Changes |
| Other Study ID Numbers: | CDR0000465498, URCC-U1505, GENENTECH-AVF3328S |
| Study First Received: | March 29, 2006 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 recurrent non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Vinorelbine Vinblastine Bevacizumab |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013