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A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)


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

Thank you

Trial Information

A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)


OBJECTIVES:

- Determine the maximum tolerated dose (MTD) of gemcitabine when administered with
carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin
in patients with stage IIIA or IIIB non-small cell lung cancer.

- Determine the MTD of gemcitabine and paclitaxel when administered with thoracic
radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel.
Patients are sequentially assigned to 1 of 3 treatment regimens.

- Regimen A: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, 22, 29, and
43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1.

- Regimen B (closed to accrual as of 5/13/03): Patients receive gemcitabine and thoracic
radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1, 8, 22, 29,
and 43.

- Regimen C: Patients receive gemcitabine and thoracic radiotherapy as in regimen A and
paclitaxel IV over 1 hour on days 1, 8, 22, 29, and 43.

At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine
IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days
71 and 92.

The first 6 patients enrolled receive regimen A to determine the safety of the initial dose
of gemcitabine. After completion of regimen A, cohorts of 3-6 patients receive escalating
doses of gemcitabine in regimen B (closed to accrual as of 5/13/03) until the maximum
tolerated dose (MTD) is determined. In a separate sequence, cohorts of 3-6 patients receive
alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is
determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients
experience dose-limiting toxicity.

Patients are followed at 3 months, 6 months, every 3 months for 1 year, every 6 months for 2
years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 29 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed loco-regionally advanced non-small cell
lung cancer meeting one of the following staging criteria:

- Medically inoperable stage IIIA

- Unresectable stage IIIA or IIIB

- Measurable disease on three-dimensional planning CT scan

- No post-resection intrathoracic tumor recurrence

- No pleural effusion on chest x-ray except those occurring after attempted thoracotomy
or other invasive thoracic procedure

- No evidence of small cell histology

- No evidence of hematogenous or distant metastases

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count at least 100,000/mm^3

- Absolute granulocyte count at least 2,000/mm^3

- Hemoglobin at least 8.0 g/dL

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 1.5 times upper limit of normal (unless caused by documented
benign disease)

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No myocardial infarction within the past 6 months

- No symptomatic heart disease, including angina, congestive heart failure, or
uncontrolled arrhythmia

Pulmonary:

- FEV_1 greater than 1,000 mL

Other:

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

- No weight loss of more than 10% in 3 months prior to diagnosis

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior thoracic or neck radiotherapy

Surgery:

- See Disease Characteristics

- No prior complete or subtotal tumor resection

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Hak Choy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068622

NCT ID:

NCT00016315

Start Date:

May 2001

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

Name

Location

Akron City HospitalAkron, Ohio  44304
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Danville Regional Medical CenterDanville, Virginia  24541
Dale and Frances Hughes Cancer CenterEast Stroudsburg, Pennsylvania  18301
Cancer Care Center, IncorporatedSalem, Ohio  44460