Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study
18 Years
N/A
Both
Lung Cancer
Trial Information
Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study
OBJECTIVES:
Primary
- Determine the efficacy of cisplatin and irinotecan followed by carboplatin, etoposide,
and radiotherapy, in terms of 2-year survival, in patients with limited stage small
cell lung cancer.
Secondary
- Determine the overall response rate, overall survival, and failure-free survival of
patients treated with this regimen.
- Determine the response rate in patients treated with induction therapy comprising
irinotecan and cisplatin.
- Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 60 minutes and irinotecan IV over
90 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the
absence of disease progression or unacceptable toxicity.
- Consolidation therapy: Immediately after the completion of induction therapy, patients
receive carboplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on
days 1-3. Treatment repeats every 21 days for 3 courses in the absence of disease
progression or unacceptable toxicity.
- Radiotherapy: Beginning on day 1 of consolidation therapy, patients undergo chest
radiotherapy daily 5 days a week for 6-7 weeks.
After the completion of consolidation therapy, patients who achieve a complete remission or
very good partial remission may undergo prophylactic radiotherapy to the brain.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 15-24
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Limited stage disease, defined as the following:
- Disease restricted to 1 hemithorax with regional lymph node metastases,
including hilar, ipsilateral, or contralateral mediastinal lymph nodes
- No clinically suspected or confirmed supraclavicular lymph node metastases
- No pathologically enlarged contralateral hilar lymph nodes
- No pleural effusions that are visible on plain chest radiographs, whether
they are cytologically positive or negative
- Unidimensionally measurable disease
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Pleural/pericardial effusions are not considered measurable
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No "currently active" second malignancy except nonmelanoma skin cancer
- Patients are not considered to have a "currently active" malignancy if they have
completed therapy and are considered by their physician to be at less than 30%
risk of relapse
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- No prior chemotherapy for SCLC
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy except the following:
- Steroids for adrenal failure
- Hormones administered for non-disease-related conditions (e.g., insulin for
diabetes)
- Intermittent dexamethasone as an antiemetic or adjunct to prophylactic cranial
radiotherapy
Radiotherapy
- See Endocrine therapy
- No prior radiotherapy for SCLC
- No concurrent intensity-modulated radiotherapy
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy, in terms of survival, at 2 years after initiation of study treatment
Safety Issue:
No
Principal Investigator
Michael J. Kelley, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Duke University
Authority:
United States: Federal Government
Study ID:
CDR0000339871
NCT ID:
NCT00072527
Start Date:
November 2003
Completion Date:
August 2019
Related Keywords:
- Lung Cancer
- limited stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey 08103-1489 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| North Shore University Hospital | Manhasset, New York 11030 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
| Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
| Fairview University Medical Center - University Campus | Minneapolis, Minnesota 55455 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Greenville Hospital System Cancer Center | Greenville, South Carolina 29605 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
| Comprehensive Cancer Center at Moore Regional Hospital | Pinehurst, North Carolina 28374 |
| Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
| Miriam Hospital at Lifespan | Providence, Rhode Island 02906 |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Beebe Medical Center | Lewes, Delaware 19958 |
| St. Francis Hospital | Wilmington, Delaware 19805 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Galesburg Clinic | Galesburg, Illinois 61401 |
| InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| Valley Cancer Center | Spring Valley, Illinois 61362 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
| Mercy Memorial Hospital System | Monroe, Michigan 48162 |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
| Frisbie Memorial Hospital | Rochester, New Hampshire 03867 |
| Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
| Community General Hospital of Greater Syracuse | Syracuse, New York 13215 |
| Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
| Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Eureka Hospital | Eureka, Illinois 61530 |
| Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
| Saint Joseph Regional Medical Center - Plymouth Campus | Plymouth, Indiana 46544 |
| Hudner Oncology Center at Saint Anne's Hospital | Fall River, Massachusetts 02721 |
| Saint Luke's Hospital | Chesterfield, Missouri 63017 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
| Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
| Faxton Regional Cancer Center | Utica, New York 13502 |
| Comprehensive Cancer Center at Gaston Memorial | Gastonia, North Carolina 28053-1747 |
