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Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In Patients More Than Or Equal To 65 Years Of Age: A Phase II Trial of Efficacy and Patients Perceived Preference for Oral Therapy


Phase 2
65 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In Patients More Than Or Equal To 65 Years Of Age: A Phase II Trial of Efficacy and Patients Perceived Preference for Oral Therapy


OBJECTIVES: I. Determine the objective response rate in elderly patients with stage IIIB or
IV non-small cell lung cancer treated with oral vinorelbine. II. Determine the time to
progression in patients treated with this drug. III. Determine the toxicity of this drug in
these patients. IV. Determine whether there is a perceived preference for this oral
administration in these patients. V. Determine the quality of life of these patients when
treated with this drug. VI. Assess individual variation in responses, pharmacokinetic
parameters, and/or biological correlates in patients treated with this drug.

OUTLINE: Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every
28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed
every 3 months for 5 years.

PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study within 1.3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB or IV non-small cell lung
cancer Measurable disease At least 1 lesion that is 2.0 cm or more in longest diameter CNS
metastases allowed if previously treated and clinically stable for at least 8 weeks prior
to study No meningeal carcinomatosis Participation in translational research component of
this study is mandatory

PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10.0
g/dL Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 2.0
mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Other: No dysphagia
or inability to swallow capsules intact No peripheral neuropathy grade 2 or greater No
other significant medical condition that would preclude study No active infection within
the past 2 weeks No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for this disease within the past 5 years Endocrine therapy: Not specified
Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior
radiotherapy to more than 25% of bone marrow No prior radiotherapy to measurable lesion
unless documented progression after therapy No concurrent radiotherapy, including
palliative radiotherapy Surgery: At least 3 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068398

NCT ID:

NCT00008333

Start Date:

April 2001

Completion Date:

Related Keywords:

  • 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

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001