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A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide


Phase 2
18 Years
N/A
Not Enrolling
Both
Extensive Stage Small Cell Lung Cancer

Thank you

Trial Information

A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide


OBJECTIVES:

Primary

- Evaluate the response frequency of patients with extensive stage small cell lung cancer
treated with topotecan, cisplatin, and etoposide and with irinotecan, cisplatin, and
etoposide.

- Evaluate the toxic effects of these regimens in these patients.

- Evaluate the duration of response and survival of patients treated with these regimens.

Secondary

- To investigate the occurrence of various breast cancer resistance protein (BCRP)
alleles in patients receiving topoisomerase 1 inhibitors and their impact on clinical
response and toxicity.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I (PET): Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3;
etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on
days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and
continuing until blood counts recover.

- Arm II (PIE): Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60
minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

ACTUAL ACCRUAL: A total of 140 patients were accrued for this study.

Inclusion Criteria


INCLUSION CRITERIA:

- Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated
within 2 weeks prior to randomization

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3

- Disease-free for >=5 years if had a prior second malignancy other than treated basal
cell or squamous cell skin cancer, or carcinoma in situ of the cervix

- Adequate hematologic, hepatic and renal function determined by the following tests,
within 4 weeks prior to randomization: white blood cell (WBC) >=4000/mm3 and
platelets >=100,000/mm3; bilirubin <= upper limit of normal; serum glutamic pyruvate
transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic
transaminase (SGOT) or aspartate transaminase( AST) <=2.5 x upper limit of normal if
no demonstrable liver metastases or <=5 times upper limit of normal in the presence
of liver metastases; Calculated creatinine clearance >=30 using the formulas in the
protocol

- Age 18 and older

- Strongly advised to use an accepted and effective method of contraception

- Those with central nervous system (CNS) metastases were eligible if the metastases
were treated without advancing symptoms prior to the initiation of chemotherapy

- Those receiving erythropoietin could continue to receive it

EXCLUSION CRITERIA:

- Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central
nervous system (CNS) metastases

- Prior chemotherapy for this disease

- Pregnant or lactating

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)

Outcome Description:

Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

Outcome Time Frame:

Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.

Safety Issue:

No

Principal Investigator

Joseph Aisner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000276590

NCT ID:

NCT00057837

Start Date:

March 2004

Completion Date:

August 2012

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • extensive stage small cell lung cancer
  • Topotecan
  • Etoposide
  • Cisplatin
  • Irinotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Northern New JerseyHackensack, New Jersey  07601
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
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
St. Rita's Medical CenterLima, Ohio  45801
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Memorial Hospital of South BendSouth Bend, Indiana  46601
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Medical Center of Central GeorgiaMacon, Georgia  31201
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Chester County HospitalWest Chester, Pennsylvania  19380
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Southwest Medical CenterLiberal, Kansas  67901
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Bettendorf, Iowa  52722
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
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
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Hematology and Oncology Associates of Northeastern PennsylvaniaScranton, Pennsylvania  18510
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
Central Pennsylvania Hematology and Medical Oncology Associates, PCLemoyne, Pennsylvania  17043
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Dale and Frances Hughes Cancer Center at Pocono Medical CenterEast Stroudsburg, Pennsylvania  18301
Associates in Hematology-Oncology, PC at Crozer Regional Cancer CenterUpland, Pennsylvania  19013
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia Fields, Illinois  60461
Clarian Arnett Cancer CareLafayette, Indiana  47904
Regional Cancer Center at Sacred Heart HospitalEau Claire, Wisconsin  54701
Hematology & Oncology CareMoline, Illinois  61265