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Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age


Phase 2
65 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age


OBJECTIVES:

Primary

- Determine the 6-month progression status of older patients with unresectable or
metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin
and paclitaxel.

Secondary

- Determine the response rate in patients treated with these regimens.

- Determine the quality of life of patients treated with these regimens.

- Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR)
concentrations predict response in patients treated with these regimens.

- Correlate the presence of social support for these patients with toxicity and efficacy
of these regimens.

- Determine whether social support for these patients differs according to gender.

- Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy
regimen for these patients.

Tertiary

- Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of
prespecified germline and tumor genes, and plasma and urine proteomic patterns with
response rate and time to progression of patients receiving treatment in group I.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2
treatment groups as determined by their treating physician.

- Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

- Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes
on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the
absence of disease progression or unacceptable toxicity. After completion of
chemotherapy and in the absence of disease progression, patients receive oral gefitinib
as in group I.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be
accrued for this study within 1.7 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Metastatic or unresectable disease

- Measurable disease

- At least 1 lesion at least 2.0 cm

- Disease must be completely outside prior radiotherapy port OR documented disease
progression since the completion of radiotherapy

- No meningeal carcinomatosis

- No untreated brain metastases

- Current metastatic CNS disease must have been treated and clinically stable for
at least 2 weeks prior to study chemotherapy

- No potentially curative treatment options available (e.g., chemotherapy with surgery
or radiotherapy)

PATIENT CHARACTERISTICS:

Age

- 65 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

- Hemoglobin at least 10.0 g/dL

Hepatic

- Bilirubin no greater than 2.0 mg/dL

- No uncontrolled hepatic disease

Renal

- Creatinine no greater than 2 times upper limit of normal

- No uncontrolled renal disease

Cardiovascular

- No uncontrolled cardiac disease

Pulmonary

- No clinically active interstitial lung disease

- Asymptomatic, chronic stable radiographic changes allowed

- No uncontrolled respiratory disease

Other

- Fertile patients must use effective contraception

- Able and willing to complete questionnaires alone or with assistance

- No known hypersensitivity to gefitinib or any of its excipients

- No active infection within the past 2 weeks

- No other prior malignancy within the past 5 years except basal cell skin cancer

- No grade 2 or greater peripheral neuropathy (CTC v2.0)

- No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)

- No dysphagia or inability to swallow intact capsules

- No significant medical condition that would preclude study treatment or follow-up

- No severe or uncontrolled systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No prior chemotherapy for metastatic NSCLC

Endocrine therapy

- Concurrent steroids allowed provided the dose is not changed

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No prior radiotherapy to more than 25% of marrow-containing skeleton

- No concurrent radiotherapy (including palliative)

Surgery

- See Disease Characteristics

- At least 3 weeks since prior major surgery

- No surgery within 7 days after study participation

Other

- More than 30 days since prior non-FDA approved investigational drugs

- No concurrent oral retinoids

- No concurrent CYP3A4-inducing agents, including the following:

- Carbamazepine

- Oxcarbazepine

- Modafinil

- Ethosuximide

- Griseofulvin

- Nafcillin

- Phenobarbital

- Phenylbutazone

- Phenytoin

- Primidone

- Rifampin

- Hypericum perforatum (St. John's wort)

- Barbiturates

- Sulfinpyrazone

- No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)

- No concurrent antacids within 4 hours before, during, and within 4 hours after
gefitinib administration

- No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression status at 6 months

Safety Issue:

No

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000304453

NCT ID:

NCT00062062

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IV non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
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
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Toledo HospitalToledo, Ohio  43606
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Front Range Cancer SpecialistsFort Collins, Colorado  80528
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
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
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, P.A. - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, P.A. - KingmanKingman, Kansas  67068
Cancer Center of Kansas, P.A. - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - PrattPratt, Kansas  67124
Cancer Center of Kansas, P.A. - SalinaSalina, Kansas  67042
Cancer Center of Kansas, P.A. - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A. - Medical Arts TowerWichita, Kansas  67208
Associates in Womens Health, P.A. - North ReviewWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WinfieldWinfield, Kansas  67156
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Haematology-Oncology Associates of Ohio and Michigan, P.C.Lambertville, Michigan  48144
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Alexandria, Minnesota  56308
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Mid Dakota Clinic, P. C.Bismarck, North Dakota  58501
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Kenton Oncology, IncorporatedKenton, Ohio  43326
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Promedica Cancer Center at Flower HospitalSylvania, Ohio  43560
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Toledo Surgical SpecialistsToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
St. Anthony's Memorial HospitalEffingham, Illinois  62401
St. John's HospitalMaplewood, Minnesota  55109
Geisinger Medical GroupState College, Pennsylvania  16801
Franciscan Skemp HealthcareLa Crosse, Wisconsin  54601-4796
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Medical College of Ohio Cancer InstituteToledo, Ohio  43614
Woodwinds Health CampusWoodbury, Minnesota  55125
Cancer Center of Kansas, P.A. - Dodge CityDodge City, Kansas  67801
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer CenterSioux City, Iowa  51101
Medical X-Ray Center, P. C.Sioux Falls, South Dakota  57105