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Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)


OBJECTIVES:

- Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered
concurrently with thoracic radiotherapy alone or following 2 cycles of induction
chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer.

- Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients.

- Determine the effectiveness of concurrent radiation and gemcitabine by determining the
complete response rate, partial response rate, time to recurrence, pattern of
recurrence, and overall survival in a cohort of these patients.

OUTLINE: This is an alternating two arm, dose escalation, multicenter study.

Arm I: Patients receive twice-weekly gemcitabine as a 30 minute infusion. Concurrent
radiation therapy is administered 5 days a week for 6 weeks.

Arm II: Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a
30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1. Each cycle is 21
days. Patients then receive gemcitabine and radiation therapy as in arm I.

Cohorts of 3 patients are enrolled into each treatment arm at each dose level of
gemcitabine. Toxicity for each arm is assessed independently. Once dose limiting toxicity
(DLT) is observed at any dose level, 3 more patients are enrolled at the same dose level.
The maximum tolerated dose (MTD) is defined as the dose at which no more than 1 of 6
patients experiences grade 4 toxicity, or no more than 4 of 6 patients experience grade 3 or
worse toxicity (DLT). After the MTD is determined for each treatment arm, additional
patients are treated at that dose level for the phase II portion of the study.

Patients are followed every 3 months for 2 years, then every 4 months for the next 2 years,
and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be approximately 24-48 patients accrued into this study within
1-2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IIIA or IIIB non-small cell lung cancer that is
unicentric and inoperable, including the following cellular types:

- Squamous cell carcinoma

- Adenocarcinoma

- Bronchoalveolar carcinoma

- Large cell anaplastic carcinoma

- Non-small cell lung cancer not otherwise specified

- Tumors may be multifocal if all of disease is believed to be result of direct spread

- Disease must be fully accessible by radiotherapy ports for the entire prescribed dose

- No supraclavicular nodes or diffuse pleural involvement

- No contralateral hilar disease or an exudative, bloody, or cytologically malignant
effusion

- Measurable disease required for phase II of this study

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- ECOG 0-2

Life expectancy:

- At least 1 year

Hematopoietic:

- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin greater than 10 g/dL

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

Renal:

- BUN no greater than 1.5 times normal

- Creatinine no greater than 1.5 times normal

Pulmonary:

- FEV1 no greater than 1 liter except if tumor has negatively impacted

- pulmonary function

Other:

- No other serious medical or psychiatric illness

- No prior lung cancer except if free of disease for more than 3 years

- No other prior malignancy except nonmelanoma skin cancer or if free of

- disease for more than 1 year

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior thoracic radiotherapy

- Concurrent radiotherapy to other anatomic sites allowed

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

•Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Arthur William Blackstock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000066052

NCT ID:

NCT00003202

Start Date:

January 1998

Completion Date:

July 2006

Related Keywords:

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

Name

Location

Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082