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Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005059
Enrollment
51
Registered
2004-05-26
Start date
2000-01-31
Completion date
2006-04-30
Last updated
2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IV non-small cell lung cancer

Brief summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating patients who have metastatic or recurrent unresectable non-small cell lung cancer.

Detailed description

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.

Interventions

DRUGcarboplatin
DRUGpaclitaxel

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
response rateUp to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026