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Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer


- Determine survival and time to treatment failure in patients with stage IIIB non-small
cell lung cancer treated with induction docetaxel, cisplatin, and radiotherapy followed
by consolidation docetaxel.

- Determine the response rate in these patients when treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1,
8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients
also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.

At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy,
patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6
months for 1 year.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.

Inclusion Criteria


- Histologically or cytologically confirmed stage IIIB non-small cell lung cancer

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Pathologically or radiographically documented positive N3 nodes

- No positive supraclavicular or scalene lymph nodes with disease extending into
the cervical region OR

- T4 tumor invading any of the following:

- Mediastinum

- Heart

- Great vessels

- Trachea

- Esophagus

- Vertebral body

- Carina

- No brain, contralateral chest, liver, or adrenal metastases

- No more than 1 parenchymal lesion

- No malignant pleural effusions unless they are only visible on CT scan or deemed too
small to tap

- No pericardial effusions

- Measurable disease



- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

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


- Not specified


- Creatinine clearance at least 50 mL/min


- One of the following:

- FEV1 at least 2.0 L

- Predicted FEV1 of contralateral lung greater than 800 mL

- Predicted post-treatment FEV1 at least 1.0 L


- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- No concurrent growth factors during induction chemoradiotherapy


- No prior chemotherapy for lung cancer

Endocrine therapy:

- Not specified


- No prior radiotherapy for lung cancer


- No prior surgical resection of lung cancer

- Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery
for determining diagnosis, stage, or potential resectability allowed

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Raja Mudad, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Tulane University Health Sciences Center


United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

March 2005

Related Keywords:

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



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Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
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University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
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Tripler Army Medical Center Honolulu, Hawaii  96859-5000
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University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
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CCOP - Duluth Duluth, Minnesota  55805
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CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Albany Albany, New York  12208
CCOP - Columbus Columbus, Ohio  43206
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CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
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MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
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Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
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Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
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University of Kansas Medical Center Kansas City, Kansas  66160-7353
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Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
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Providence Hospital - Southfield Southfield, Michigan  48075-9975
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