Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified September 2012 by University of Nebraska
Sponsor:
University of Nebraska
Collaborator:
Information provided by (Responsible Party):
Apar Kishor Ganti, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00602797
First received: January 15, 2008
Last updated: September 19, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving vinorelbine tartrate together with paclitaxel works in treating older patients with advanced non-small cell lung cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer |
Drug: vinorelbine tartrate Drug: paclitaxel Procedure: quality-of-life assessment Other: questionnaire administration |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by University of Nebraska:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: Every 3 months for 2 years and then every 6 months for 5 years ] [ Designated as safety issue: No ]Defined as the time from 1st therapy until first documentation of clinical progression or relapse or death. The Kaplan-Meier method will be used to estimate time to event distributions.
- Safety [ Time Frame: At weeks 4, 9, 12 and 17 ] [ Designated as safety issue: Yes ]Interim monitoring after 10 patients and 19 patients have completed study. Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 must be used to grade the severity of adverse events (AEs).
- Response rate [ Time Frame: After each cycle based on RECIST criteria ] [ Designated as safety issue: No ]The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Quality of life [ Time Frame: At baseline and weeks 9 and 17 ] [ Designated as safety issue: No ]QOL will be assessed by Functional Assessment of Cancer Therapy - Lung (FACT-L) version 4.0 questionnaire.
| Estimated Enrollment: | 29 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (chemotherapy)
Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
|
Drug: vinorelbine tartrate
Given IV
Other Names:
Drug: paclitaxel
Given IV
Other Names:
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
|
Detailed Description:
OBJECTIVES:
I. To assess the safety and efficacy of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer.
II. To assess the response rate of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer.
III. To assess the quality of life of elderly patients with advanced non-small cell lung cancer during administration of weekly paclitaxel and vinorelbine.
OUTLINE:
Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologically proven non-small cell lung cancer with evidence of distant metastases/malignant pleural effusion
- Measurable disease on imaging studies in 2 dimensions
- No previous therapy with either paclitaxel or vinorelbine, or any chemotherapy for the past five years
- Patients who have had a previous resection for their lung cancer and present with recurrent disease will be eligible
- Patients with other prior malignancies will be included, provided they have been disease-free for at least five years
- Patients with adequately treated basal cell or squamous cell carcinoma of the skin, adequately treated carcinoma in-situ of the cervix and hormone sensitive prostate cancer will be eligible
- Karnofsky score >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2)
- White blood cell (WBC) count >= 3,500/mm^3, OR
- Absolute neutrophil count (ANC) >= 1,500/ul
- Platelet count >= 100,000/mm^3
- Serum creatinine less than 1.5 times the upper limits of normal
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 1.5 times the upper limits of normal
- Serum alkaline phosphatase less than 2.5 times the upper limits of normal
- No active serious infections or other condition precluding chemotherapy
- Non-pregnant and non-nursing
- Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on the study
- Able to give informed consent
- Able to return for treatment and follow-up as specified in the protocol
Exclusion Criteria:
- Known hypersensitivity to any component of vinorelbine or paclitaxel or other required drugs in the study
- Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- Inability to fulfill the requirements of the protocol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602797
Locations
| United States, Nebraska | |
| Saint Francis Medical Center | Recruiting |
| Grand Island, Nebraska, United States, 68803 | |
| Contact: Mehmet S. Copur 308-398-6518 mcopur@sfmc-gi.org | |
| Principal Investigator: Mehmet S. Copur | |
| Great Plains Regional Medical Center | Recruiting |
| North Platte, Nebraska, United States, 69101 | |
| Contact: Irfan A. Vaziri 308-696-7864 vazirii@mail.gprmc.com | |
| Principal Investigator: Irfan A. Vaziri | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-6805 | |
| Contact: Apar K. Ganti 402-559-6210 aganti@unmc.edu | |
| Principal Investigator: Apar K. Ganti | |
| Omaha Veterans Administration Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68105 | |
| Contact: Apar K. Ganti 402-995-4171 aganti@unmc.edu | |
| Principal Investigator: Apar K. Ganti | |
Sponsors and Collaborators
University of Nebraska
Investigators
| Principal Investigator: | Apar Ganti | University of Nebraska |
More Information
No publications provided
| Responsible Party: | Apar Kishor Ganti, MD, Principal Investigator, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00602797 History of Changes |
| Other Study ID Numbers: | 339-07, NCI-2009-01584, P30CA036727 |
| Study First Received: | January 15, 2008 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Vinorelbine |
Vinblastine Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013