Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer

NCT ID: NCT00602797

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-17
• Study Completion Date: 2014-08-01

Brief Summary

This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with non-small cell lung cancer that has spread to other placed in the body. 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, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells.

Detailed Description

PRIMARY 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.

Conditions

Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (vinorelbine tartrate, paclitaxel)

Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Given IV

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Vinorelbine Tartrate

Intervention Type: DRUG

Given IV

Interventions

Paclitaxel

Given IV

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Vinorelbine Tartrate

Given IV

Intervention Type: DRUG

Other Intervention Names

Anzatax; Asotax; Bristaxol; Praxel; Taxol; Taxol Konzentrat; Quality of Life Assessment; Biovelbin; Eunades; KW-2307; Navelbine; Navelbine Ditartrate; Vinorelbine Ditartrate

Eligibility 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Apar K Ganti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

CHI Health Saint Francis

Grand Island, Nebraska, United States

Great Plains Regional Medical Center

North Platte, Nebraska, United States

Veterans Administration Medical Center, Omaha

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, United States

Countries

United States

References

Huerter MM, Meza JL, Copur MS, Tolentino A, Marr AS, Ketcham M, DeSpiegelaere H, Kruse S, Kos ME, Swenson K, Radniecki SE, Kessinger A, Ganti AK. Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study. J Geriatr Oncol. 2017 Jan;8(1):18-22. doi: 10.1016/j.jgo.2016.07.006. Epub 2016 Aug 1.

Reference Type: RESULT

PMID: 27491498 (View on PubMed)

Other Identifiers

NCI-2009-01584

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA036727

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0339-07-FB

Identifier Type: -

Identifier Source: org_study_id