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Sequential and Concomitant Chemoradiotherapy With Gemcitabine-Based Chemotherapy for Inoperable Stage IIIa and IIIb Non-Small Cell Lung Cancer: A Phase I/IIa Study

Phase 1/Phase 2
Not Enrolling
Lung Cancer

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Trial Information

Sequential and Concomitant Chemoradiotherapy With Gemcitabine-Based Chemotherapy for Inoperable Stage IIIa and IIIb Non-Small Cell Lung Cancer: A Phase I/IIa Study

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of
gemcitabine and paclitaxel in combination with radiotherapy in patients with locally
advanced stage IIIA or IIIB non-small cell lung cancer. II. Assess response rate, duration
of response, disease free survival and failure in this patient population on this regimen.
III. Determine the pharmacokinetics of gemcitabine and paclitaxel during the
chemoradiotherapy phase.

OUTLINE: This is a dose escalation study of gemcitabine. Induction phase: Patients receive
gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 2 courses. Chemoradiotherapy phase: Patients receive
paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into
paclitaxel infusion on day 1 of weeks 6, 9, and 12. Patients undergo conventional chest
radiotherapy on Monday though Friday for weeks 6-11. Cohorts of 3-5 patients receive
escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose at which at least 2 of 5 patients experience dose limiting

PROJECTED ACCRUAL: A minimum of 17 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced,
unresectable non- small cell lung cancer Stage IIIA or IIIB Local, unresectable recurrence
after primary surgery allowed Measurable or evaluable disease No contralateral pleural
effusion(s) or noncontiguous pleural implants T4 tumors with small ipsilateral pleural
effusions allowed

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5
mg/dL SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine no
greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior
myocardial infarction within the past 6 months No congestive heart failure No uncontrolled
arrhythmias Pulmonary: FEV1 greater than 800 mL Other: Not pregnant Negative pregnancy
test Fertile patients must use effective contraception No history of hypersensitivity to
drugs formulated in Cremophor EL No other malignancy within the past 5 years, except:
Nonmelanomatous skin cancer Carcinoma in situ of the cervix No overt psychosis or other
major debilitating disorder that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Francisco Robert, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294