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Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study


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

Thank you

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 CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Rhode Island HospitalProvidence, Rhode Island  02903
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University HospitalCamden, New Jersey  08103-1489
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
North Shore University HospitalManhasset, New York  11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Fairview University Medical Center - University CampusMinneapolis, Minnesota  55455
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Comprehensive Cancer Center at Moore Regional HospitalPinehurst, North Carolina  28374
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Miriam Hospital at LifespanProvidence, Rhode Island  02906
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Elkhart General HospitalElkhart, Indiana  46515
Beebe Medical CenterLewes, Delaware  19958
St. Francis HospitalWilmington, Delaware  19805
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Union Hospital Cancer Center at Union HospitalElkton MD, Maryland  21921
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Frisbie Memorial HospitalRochester, New Hampshire  03867
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Community General Hospital of Greater SyracuseSyracuse, New York  13215
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Danville Regional Medical CenterDanville, Virginia  24541
Eureka HospitalEureka, Illinois  61530
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Saint Joseph Regional Medical Center - Plymouth CampusPlymouth, Indiana  46544
Hudner Oncology Center at Saint Anne's HospitalFall River, Massachusetts  02721
Saint Luke's HospitalChesterfield, Missouri  63017
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Pardee Memorial HospitalHendersonville, North Carolina  28791
Faxton Regional Cancer CenterUtica, New York  13502
Comprehensive Cancer Center at Gaston MemorialGastonia, North Carolina  28053-1747