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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 CenterSeattle, Washington  98109
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
St. Rita's Medical CenterLima, Ohio  45801
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
LDS HospitalSalt Lake City, Utah  84143
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
CCOP - NorthwestTacoma, Washington  98405-0986
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Wesley Medical CenterWichita, Kansas  67214
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Poudre Valley HospitalFort Collins, Colorado  80524
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Mecosta County Medical CenterBig Rapids, Michigan  49307
Community Cancer Center of MonroeMonroe, Michigan  48162
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Bismarck Cancer CenterBismarck, North Dakota  58501
Wood County Oncology CenterBowling Green, Ohio  43402
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Arch Medical Services, Incorporated at Center for Cancer Care and ResearchSaint Louis, Missouri  63141
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Flower Hospital Cancer CenterSylvania, Ohio  43560
Northwest Cancer Specialists at Rose Quarter Cancer CenterPortland, Oregon  97227
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
St. Joseph Cancer CenterBellingham, Washington  98225
Providence Centralia HospitalCentralia, Washington  98531-9027
Columbia Basin HematologyKennewick, Washington  99336
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Auburn Regional Center for Cancer CareAuburn, Washington  98002
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Kinston Medical SpecialistsKinston, North Carolina  28501
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
AnMed Cancer CenterAnderson, South Carolina  29621
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Northwest Cancer Specialists at Vancouver Cancer CenterVancouver, Washington  98684