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A Phase II Study of Non-Small Cell Cancer of the Lung Utilizing Low-Dose Weekly Therapy of Taxotere and Carboplatin

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase II Study of Non-Small Cell Cancer of the Lung Utilizing Low-Dose Weekly Therapy of Taxotere and Carboplatin

OBJECTIVES: I. Determine the effectiveness of low dose docetaxel and carboplatin by response
rate, response duration, and time to progression in patients with stage IIIB or IV non-small
cell lung cancer. II. Determine the side effects and toxicity profile of docetaxel when
given in combination with carboplatin in these patients.

OUTLINE: This is open label study. Patients receive docetaxel IV over 1 hour followed by
carboplatin IV over 30 minutes once a week for 4 weeks. Patients receive at least 2 courses
(8 weeks) of treatment. Courses are further repeated in the absence of unacceptable toxicity
and disease progression.

PROJECTED ACCRUAL: There will be 20-38 patients accrued into this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB with metastatic pleural
effusion or metastatic stage IV non-small cell lung cancer Large cell Adenocarcinoma
Squamous cell Bronchioalveolar carcinoma Undifferentiated No small cell or carcinoid
histologies At least 1 bidimensionally measurable or evaluable indicator lesion Measurable
or evaluable indicator lesion(s) must be completely outside the radiation portal or there
must be proof of disease progression No current CNS metastases at study entry No meningeal

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
Greater than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT
and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase less than ULN, OR
alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT less than ULN Renal:
Creatinine clearance at least 50 mL/min Other: No concurrent illness that would effect
assessment of this study Not pregnant or nursing Effective contraception required of all
fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic
chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics Prior radiotherapy for non-small cell lung
cancer allowed Radiotherapy for new brain metastases (other than leptomeningeal disease)
is allowed during study, but chemotherapy is stopped during and for 2 weeks following
radiotherapy Concurrent radiotherapy to other sites allowed if there is no objective
criteria for disease progression Surgery: Not specified Other: No other concurrent
experimental drug

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Raj Sadasivan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hope Cancer Institute, Inc.


United States: Federal Government

Study ID:




Start Date:

July 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Bethany Medical Center Kansas City, Kansas  66102
Heartland Cancer Research Network Kansas City, Kansas  66102