S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors

Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062439
• Other study ID #: CDR0000304777
• Secondary ID: U10CA032102S0220
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2003
• Last updated: October 30, 2013
• Start date: July 2003
• Est. completion date: December 2010

Study information

• Verified date: October 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.

Description:

OBJECTIVES:

• Determine the feasibility 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin
During induction:50 mg/m2,IV on Days 1, 8, 29 & 36. In any appropriate vehicle over 60 minutes
• docetaxel
During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes
• etoposide
During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes.

Procedure:
• conventional surgery
If, based upon the evaluation in Section 7.4a, there is no evidence of progression (see Section 10.2d for definition), patients will proceed to the next appropriate step: Registration #2 and surgery followed by Registration #3 and additional chemotherapy (Sections 7.5 and 7.6). Response determinations (CR,PR, SD) will be required. If criteria for progressive measurable or nonmeasurable disease (see Section 10.0) are met, the patient will then be removed from protocol treatment and receive follow-up according to the schedule. Surgery will be performed 3 - 7 weeks after completion of chemoradiotherapy.

Radiation:
• radiation therapy
Radiotherapy is to begin within 24 hours following the start of chemotherapy. Day 1 of radiotherapy must be a Monday, Tuesday or Wednesday, but no later in the week to insure simultaneous therapy for the majority of each chemotherapy cycle. The total dose to the prescription point will be 4,500 cGy given in 25 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter.

Locations

Country	Name	City	State
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	American Fork Hospital	American Fork	Utah
United States	AnMed Cancer Center	Anderson	South Carolina
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	Auburn Regional Center for Cancer Care	Auburn	Washington
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Sandra L. Maxwell Cancer Center	Cedar City	Utah
United States	Providence Centralia Hospital	Centralia	Washington
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	CCOP - Duluth	Duluth	Minnesota
United States	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota
United States	Miller - Dwan Medical Center	Duluth	Minnesota
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	St. Francis Hospital	Federal Way	Washington
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan
United States	Metro Health Hospital	Grand Rapids	Michigan
United States	Big Sky Oncology	Great Falls	Montana
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	St. Peter's Hospital	Helena	Montana
United States	Holland Community Hospital	Holland	Michigan
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Foote Memorial Hospital	Jackson	Michigan
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Columbia Basin Hematology	Kennewick	Washington
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Kinston Medical Specialists	Kinston	North Carolina
United States	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Southwest Medical Center	Liberal	Kansas
United States	Lima Memorial Hospital	Lima	Ohio
United States	St. Rita's Medical Center	Lima	Ohio
United States	Logan Regional Hospital	Logan	Utah
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital - Monroe	Monroe	Michigan
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah
United States	Hackley Hospital	Muskegon	Michigan
United States	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Northwest Cancer Specialists at Rose Quarter Cancer Center	Portland	Oregon
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	Arch Medical Services, Incorporated at Center for Cancer Care and Research	Saint Louis	Missouri
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	Missouri Baptist Cancer Center	St. Louis	Missouri
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington
United States	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Munson Medical Center	Traverse City	Michigan
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Northwest Cancer Specialists at Vancouver Cancer Center	Vancouver	Washington
United States	St. John Macomb Hospital	Warren	Michigan
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Wesley Medical Center	Wichita	Kansas
United States	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas

Sponsors (7)

Lead Sponsor	Collaborator
Southwest Oncology Group	American College of Surgeons, Canadian Cancer Trials Group, Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, National Cancer Institute (NCI), North Central Cancer Treatment Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.	Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.	After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel	No
Secondary	Adverse Events	Only adverse events that are possibly, probably or definitely related to study drug are reported.	Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.	Yes
Secondary	Overall Survival	The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.	daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.	No
Secondary	Progression-Free Survival at 3 Years	Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.	At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment.	No
Secondary	Response	Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.	After completion of induction therapy.	No