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Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

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.

Outcome Time Frame:

Every 3 months for 2 years and then every 6 months for 5 years

Safety Issue:

No

Principal Investigator

Apar Ganti

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Institutional Review Board

Study ID:

339-07

NCT ID:

NCT00602797

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Great Plains Regional Medical CenterNorth Platte, Nebraska  69101-6598
Saint Francis Medical CenterGrand Island, Nebraska  68802
Omaha Veterans Administration Medical CenterOmaha, Nebraska  68105