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A Phase II Trial of Induction Chemoradiotherapy With Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)


Phase 2
N/A
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Phase II Trial of Induction Chemoradiotherapy With Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)


OBJECTIVES:

- Determine the feasbility of administering induction chemoradiotherapy comprising
cisplatin and etoposide followed by surgical resection and adjuvant docetaxel in
patients with non-small cell lung cancer involving the superior sulcus (Pancoast
tumors).

- Determine overall survival of patients treated with this regimen.

- Determine time to progression in patients treated with this regimen.

- Determine confirmed and unconfirmed and complete and partial response during induction
in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE:

- Induction chemoradiotherapy: Patients receive etoposide IV over 1 hour on days 1-5 and
29-33 and cisplatin IV over 1 hour on days 1, 8, 29, and 36. Patients also undergo
concurrent radiotherapy once daily 5 days a week for 5 weeks.

Within 2-4 weeks after completion of induction chemoradiotherapy, patients undergo disease
evaluation. Patients with no evidence of local or overall disease progression undergo a
thoracotomy within 3-7 weeks. Patients who do not qualify for surgery proceed to
consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete.

- Consolidation chemotherapy: Within 3-8 weeks after thoracotomy, patients with no
evidence of disease progression receive docetaxel IV over 1 hour on day 1. Treatment
repeats every 21 days for up to 3 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for
3 years.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer

- Any of the following stages due to involvement of the superior sulcus:

- Stage IIB (T3, N0), IIIA (T3, N1), or IIIB (T4, N0-1)

- Newly diagnosed

- Primary bronchogenic

- Must meet 1 of the following tumor involvement criteria:

- An apical tumor associated with the Pancoast syndrome (arm or shoulder pain
and/or neurologic findings corresponding to the roots of C-8 and/or T-1 or the
inferior trunk of the bronchial plexus with or without Horner's syndrome)
without rib or vertebral body involvement

- Superior sulcus tumors with involvement of the chest wall (T3), usually ribs 1
and 2 by CT scan or MRI, with or without an associated Pancoast syndrome

- Superior sulcus tumors with invasion of the vertebral bodies or involvement of
the subclavian vessels (T4) by CT scan or MRI, with or without an associated
Pancoast syndrome

- No more than 1 parenchymal lesion in the same lung or in both lungs

- No involvement of the following lymph node groups as determined by mediastinal
exploration* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy)
within the past 42 days:

- Single-level or multi-level ipsilateral or contralateral mediastinal nodal (N2
or N3) disease by mediastinoscopy, thoracoscopy, mediastinotomy, thoracotomy, or
transbronchial Wang needle biopsy, regardless of whether enlarged nodes are
visible or not on chest x-ray or CT scan

- Supraclavicular (scalene) nodes

- Any nodes evident on physical exam must be biopsied by fine needle
aspiration or open biopsy

- Left upper lobe tumors with left vocal cord paralysis by indirect laryngoscopy
(presumes N2 nodes in the A-P window) NOTE: *Mediastinal exploration is not
required for patients whose mediastinum is negative by both positron-emission
tomography (PET) and CT scan

- No pleural effusions except if 1 of the following criteria are met:

- Pleural effusion present before mediastinoscopy or thoracotomy with negative
cytology on 2 separate thoracenteses

- Pleural effusion present only after exploratory or staging thoracotomy, with
negative cytology on a single thoracentesis

- Present only on CT scan and too small to tap

- No pericardial effusions or superior vena cava syndrome

- No brain metastases by CT scan or MRI

- No evidence of distant metastatic disease by bone scan or PET

- Must be a candidate for potential future pulmonary resection

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Zubrod 0-2

- Patients with Zubrod performance status 2 must have an albumin level at least
0.85 times lower limit of normal and weight loss no greater than 10%

Life expectancy

- Not specified

Hematopoietic

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

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

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)*

- SGOT or SGPT no greater than 1.5 times ULN* NOTE: *Unless due to a documented benign
disease

Renal

- Creatinine clearance at least 50 mL/min

Cardiovascular

- No myocardial infarction within the past 3 months

- No active angina

- No unstable heart rhythms

- No clinically evident congestive heart failure

Pulmonary

- Preresection FEV_1 at least 2.0 L OR

- Predicted postresection FEV_1 greater than 1.0 L

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No uncontrolled peptic ulcer disease

- No grade 2 or greater sensory neuropathy

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent colony-stimulating factors during chemoradiotherapy or course 1 of
consolidation therapy

Chemotherapy

- No prior chemotherapy for lung cancer

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to the neck or thorax

- No concurrent intensity-modulated radiotherapy

Surgery

- Prior exploratory thoracotomy allowed only for diagnosis or staging purposes

Other

- No concurrent amifostine

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measurability of lesions

Safety Issue:

No

Principal Investigator

Michael J. Kraut, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Providence Cancer Institute at Providence Hospital - Southfield Campus

Authority:

United States: Federal Government

Study ID:

CDR0000304777

NCT ID:

NCT00062439

Start Date:

July 2003

Completion Date:

Related Keywords:

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

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Carle Cancer Center Urbana, Illinois  61801
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
St. Rita's Medical Center Lima, Ohio  45801
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
CCOP - Montana Cancer Consortium Billings, Montana  59101
LDS Hospital Salt Lake City, Utah  84143
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
CCOP - Northwest Tacoma, Washington  98405-0986
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
Wesley Medical Center Wichita, Kansas  67214
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
University of Virginia Cancer Center Charlottesville, Virginia  22908
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Poudre Valley Hospital Fort Collins, Colorado  80524
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Mecosta County Medical Center Big Rapids, Michigan  49307
Community Cancer Center of Monroe Monroe, Michigan  48162
Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield, Michigan  48075
Bismarck Cancer Center Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Fremont Memorial Hospital Fremont, Ohio  43420
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Fulton County Health Center Wauseon, Ohio  43567
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
St. Francis Hospital Federal Way, Washington  98003
St. Clare Hospital Lakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
Allenmore Hospital Tacoma, Washington  98411-0414
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Flower Hospital Cancer Center Sylvania, Ohio  43560
Northwest Cancer Specialists at Rose Quarter Cancer Center Portland, Oregon  97227
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
St. Joseph Cancer Center Bellingham, Washington  98225
Providence Centralia Hospital Centralia, Washington  98531-9027
Columbia Basin Hematology Kennewick, Washington  99336
Franciscan Cancer Center at St. Joseph Medical Center Tacoma, Washington  98405-3004
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Auburn Regional Center for Cancer Care Auburn, Washington  98002
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Kinston Medical Specialists Kinston, North Carolina  28501
MBCCOP - Meharry Medical College - Nashville Nashville, Tennessee  37208-3599
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
AnMed Cancer Center Anderson, South Carolina  29621
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Northwest Cancer Specialists at Vancouver Cancer Center Vancouver, Washington  98684