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A Phase II Study of Carboplatin and Paclitaxel in Elderly Patients With Metastatic or Recurrent Unresectable Non-Small Cell Lung Cancer


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

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Trial Information

A Phase II Study of Carboplatin and Paclitaxel in Elderly Patients With Metastatic or Recurrent Unresectable Non-Small Cell Lung Cancer


OBJECTIVES: I. Determine the response rate to carboplatin and paclitaxel in elderly patients
with metastatic or recurrent unresectable non-small cell lung cancer. II. Determine the
toxicity of this regimen in these patients. III. Determine if the hypothesized lack of
social support impacts the recruitment of elderly patients into clinical trials. IV.
Determine if a previously validated tool of functional status in the elderly predicts
treatment related toxicity superior to that predicted by the ECOG performance status in this
patient population.

OUTLINE: Following completion of the Lubben Social Network Scale and Frailty Questionnaire,
patients receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes on days 1,
8, and 15. Treatment repeats every 28 days for 2 courses. Patients with complete response
receive 2 additional courses of therapy. Patients with partial response or stable disease
may receive additional courses of therapy at investigator's discretion. Patients are
followed every 3 months for 5 years or until disease progression.

PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study over 27 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer Stage IV disease OR Recurrent unresectable disease No other conventional curative
or significant palliative therapies available Measurable disease At least one lesion a
minimum of one dimension in diameter of at least 20 mm No symptomatic and/or untreated CNS
metastases

PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: AST no greater than 3 times upper limit of normal Renal:
Creatinine clearance at least 40 mL/min Other: No uncontrolled infection No uncontrolled
seizure disorder No uncontrolled diabetes mellitus No other malignancies within the past 3
years except adequately treated basal or squamous cell skin cancer or noninvasive
carcinomas

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic or immunotherapy for
recurrent or metastatic disease No concurrent biologic therapy Chemotherapy: No prior
chemotherapy for recurrent or metastatic disease except as radiosensitizer No other
concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy for recurrent or metastatic disease except as adjuvant therapy At least 4
weeks since prior radiotherapy to greater than 25% of bone marrow No concurrent
radiotherapy except for CNS therapy Surgery: See Disease Characteristics 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:

CDR0000067656

NCT ID:

NCT00005059

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent 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 - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
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
Ann Arbor Hematology OncologyYpsilanti, Michigan  48197