Know Cancer

or
forgot password

Phase I-II Study of Topotecan and Paclitaxel Followed by High-Dose Thoracic Radiation Therapy With Concomitant Cisplatin/Etoposide and Amifostine in Limited-Stage Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Radiation Toxicity

Thank you

Trial Information

Phase I-II Study of Topotecan and Paclitaxel Followed by High-Dose Thoracic Radiation Therapy With Concomitant Cisplatin/Etoposide and Amifostine in Limited-Stage Small Cell Lung Cancer


OBJECTIVES:

- Determine the maximum tolerated dose of thoracic radiotherapy administered with
cisplatin, etoposide, and amifostine preceded and followed by topotecan and paclitaxel
in patients with limited stage small cell lung cancer (phase I closed to accrual as of
5/27/2004).

- Determine the two-year survival of this patient population treated with this regimen.

- Determine the two-year, progression-free local control rate in this patient population
treated with this regimen.

- Assess the tolerability of this treatment regimen in these patients.

- Determine the antitumor activity of this regimen in these patients.

- Determine the overall survival and overall time to progression in this patient
population treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of thoracic radiotherapy (TRT).

Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients
receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose
of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks
for 2 courses.

After 2 courses of topotecan and paclitaxel, patients undergo TRT twice daily for 5
consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and
amifostine SC daily prior to TRT.

At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan,
paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation.

Cohorts of 3-6 patients receive escalating doses of TRT until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
patients experience dose-limiting toxicity (phase I closed to accrual as of 5/27/2004).

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6
months for 3 years.

PROJECTED ACCRUAL: A total of 3-73 patients will be accrued for this study (phase I closed
to accrual as of 5/27/2004).

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell lung cancer

- Limited disease confined to one hemithorax, the ipsilateral supraclavicular fossa,
and encompassable within tolerable thoracic radiotherapy field

- Minimal pleural effusions (i.e., blunting of the costophrenic angle on chest
x-ray or a small effusion on CT scan) allowed

- Measurable disease

- At least one lesion accurately measured in at least 1 dimension with longest
diameter at least 20 mm

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

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)

- AST no greater than 3 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No New York Heart Association class III or IV heart disease

Pulmonary:

- FEV_1 at least 40% of predicted AND at least 1 liter

Other:

- No uncontrolled infection

- No other severe underlying diseases

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or noninvasive carcinomas (carcinoma in situ)

- No grade 2 or greater peripheral neuropathy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No hypersensitivity to E.coli-derived proteins, filgrastim (G-CSF), or any excipients
of G-CSF

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No prior hemithorax radiotherapy

Surgery

- Not specified

Other

- No prior therapy for small cell lung cancer

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Survival at 2 years

Safety Issue:

No

Principal Investigator

Scott Okuno, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068021

NCT ID:

NCT00006012

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • Radiation Toxicity
  • drug/agent toxicity by tissue/organ
  • radiation toxicity
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Radiation Injuries

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
CCOP - MeritCare HospitalFargo, North Dakota  58122
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Wesley Medical CenterWichita, Kansas  67214
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
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
St. Luke's HospitalCedar Rapids, Iowa  52402
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Bryan LGH Medical Center WestLincoln, Nebraska  68502
St. Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
MeritCare Medical GroupFargo, North Dakota  58122
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
McFarland Clinic, P.C.Ames, Iowa  50010
Mid Dakota Clinic, P.C.Bismarck, North Dakota  58501
Geisinger Medical GroupState College, Pennsylvania  16801
Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Franciscan Skemp HealthcareLa Crosse, Wisconsin  54601-4796
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
Mercy Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201