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Combination Chemotherapy With or Without Maintenance Sunitinib Malate (IND 74019; NSC 736511) For Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

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Trial Information

Combination Chemotherapy With or Without Maintenance Sunitinib Malate (IND 74019; NSC 736511) For Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study


PRIMARY OBJECTIVES:

I. To determine the phase II dose for sunitinib combined with cisplatin and etoposide.

II. Phase II: To compare the progression-free survival of patients with extensive stage
small cell lung cancer treated with cisplatin or carboplatin and etoposide followed by
maintenance sunitinib to patients receiving the same chemotherapy followed by placebo.

SECONDARY OBJECTIVES:

I. To assess the single agent response rate for sunitinib given as monotherapy after
chemotherapy.

II. To assess the overall survival of patients treated with cisplatin or carboplatin and
etoposide followed by sunitinib.

III. To evaluate the toxicity and tolerability of maintenance sunitinib after cisplatin or
carboplatin and etoposide.

IV. To determine the association between VEGF plasma levels and tumor response.

OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II
study. Patients are stratified according to treatment (cisplatin vs carboplatin), and
courses (< 6 courses vs 6 courses).

PHASE I: (close to accrual 5/17/08) Combination chemotherapy: Patients receive cisplatin or
carboplatin intravenously (IV) on day 1, etoposide IV on days 1-3, and sunitinib malate
orally (PO) once daily on days 1-14.

Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 6 patients receive escalating doses of sunitinib malate
until the recommended phase II dose is determined. The recommended phase II dose is the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity.

MAINTENANCE THERAPY: Patients receive sunitinib malate PO alone once daily. Treatment
continues in the absence of disease progression or unacceptable toxicity.

PHASE II: Combination chemotherapy: Patients receive cisplatin or carboplatin and etoposide
as in phase I.

Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 3-8 weeks after completion of combination chemotherapy or ≥ 4
courses of combination therapy, patients with a responding or stable disease are randomized
to 1 of 2 treatment arms. All patients must be euthyroid before starting on maintenance
therapy.

ARM I: Patients receive sunitinib malate PO once daily.

Treatment repeats every 3 weeks in the absence of disease progression or unacceptable
toxicity.

ARM II: Patients receive placebo PO once daily.

Treatment repeats every 3 weeks in the absence of disease progression or unacceptable
toxicity. Patients with disease progression may cross over to Arm I.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 2 years.


Inclusion Criteria:



- Histologically or cytologically confirmed small cell lung cancer

- Extensive-stage disease, defined as any of the following:

- Extrathoracic metastases

- Malignant pleural effusion

- Bilateral or contralateral supraclavicular adenopathy or contralateral
hilar adenopathy

- No limited-stage disease, defined as disease restricted to 1 hemithorax with
regional lymph node metastases, including hilar, ipsilateral and contralateral
mediastinal, and/or ipsilateral supraclavicular nodes

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- No nonmeasurable disease, including all of the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- No history of spinal cord compression or carcinomatous meningitis

- No history of brain metastases

- CTC performance status 0-1 (phase I) OR 0-2 (phase II)

- Absolute granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine clearance ≥ 70 mL/min

- Bilirubin ≤ 1.5 mg/dL

- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with
liver metastases)

- PTT ≤ 1.5 ULN

- Not pregnant or nursing

- No current active second malignancy other than non-melanoma skin cancers

- No ongoing cardiac dysrhythmias or atrial fibrillation

- QTc interval < 500 msec

- No New York Heart Association (NYHA) class III-IV heart failure within the past 12
months

- NYHA class II heart failure allowed, provided all of the following criteria are
met:

- Asymptomatic on treatment

- Prior anthracycline exposure

- Received prior central thoracic radiotherapy that included the heart in the
radiotherapy port

- None of the following within the past year:

- Myocardial infarction

- Coronary or peripheral artery bypass graft or stenting

- Severe or unstable angina

- Cerebrovascular accident, including transient ischemic attack

- Pulmonary embolism

- No hypertension that cannot be controlled by medications (i.e., blood pressure >
150/100 mm Hg despite optimal medical therapy)

- No hemoptysis within the past 4 weeks

- Patients with blood-tinged or blood-streaked sputum are eligible if < 5 mL of
blood per episode and < 10 mL of blood/24 hours

- None of the following within the past 28 days:

- Abdominal fistula

- Gastrointestinal perforation

- Intra-abdominal abscess

- Serious or nonhealing wound

- Ulcer

- Bone fracture

- No prior chemotherapy for small cell lung cancer

- At least 1 week since prior radiotherapy

- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the
following:

- Azole antifungals (e.g., ketoconazole, itraconazole)

- Diltiazem

- Clarithromycin

- Erythromycin

- Verapamil

- Delavirdine

- HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir,
nelfinavir)

- At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the
following:

- Rifampin

- Rifabutin

- Carbamazepine

- Phenobarbital

- Phenytoin

- Hypericum perforatum (St. John's wort)

- Efavirenz

- Tipranavir

- No concurrent therapeutic doses of coumarin-derivative anticoagulants

- Doses ≤ 2 mg daily for prophylaxis of thrombosis allowed

- Concurrent low molecular weight heparin allowed provided PT INR ≤ 1.5

- No other concurrent chemotherapy

- No concurrent hormonal therapy

- Concurrent steroids for adrenal failure, hormones for non-disease-related
conditions (e.g., insulin for diabetes), or intermittent dexamethasone allowed

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Highest safe dose of sunitinib malate in combination with cisplatin and etoposide (Phase I)

Outcome Time Frame:

Up to 21 days of course 1

Safety Issue:

No

Principal Investigator

Neal Ready

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00465

NCT ID:

NCT00453154

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • Recurrent Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Rhode Island HospitalProvidence, Rhode Island  02903
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Eastern Maine Medical CenterBangor, Maine  04401
Peninsula Regional Medical CenterSalisbury, Maryland  21801
Saint Anthony Medical CenterRockford, Illinois  61108
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Elkhart General HospitalElkhart, Indiana  46515
South Bend ClinicSouth Bend, Indiana  46617
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Beebe Medical CenterLewes, Delaware  19958
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Iredell Memorial HospitalStatesville, North Carolina  28677
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Eureka HospitalEureka, Illinois  61530
Graham Hospital AssociationCanton, Illinois  61520
Holy Family Medical CenterDes Plaines, Illinois  60016
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Highland General HospitalOakland, California  94602
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Miriam HospitalProvidence, Rhode Island  02906
McLeod Regional Medical CenterFlorence, South Carolina  29501
La Grange Memorial HospitalLa Grange, Illinois  60525
Duke University Medical CenterDurham, North Carolina  27710
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Larry G Strieff MD Medical CorporationOakland, California  94609
Glens Falls HospitalGlens Falls, New York  12801
Holy Cross HospitalFort Lauderdale, Florida  33308
El Camino HospitalMountain View, California  94040
New Hampshire Oncology-Hematology PAHooksett, New Hampshire  03106
University Of VermontBurlington,, Vermont  05403
Alegent Health Immanuel Medical CenterOmaha, Nebraska  68122
Alegent Health Bergan Mercy Medical CenterOmaha, Nebraska  68124
Addison Gilbert HospitalGloucester, Massachusetts  01930
Virginia Commonwealth UniversityRichmond, Virginia  
Memorial Health University Medical CenterSavannah, Georgia  31404
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Valley Medical Oncology Consultants-FremontFremont, California  94538
Bay Area Breast Surgeons IncOakland, California  94609
Bay Area Tumor Institution CCOPOakland, California  94609
Tom K Lee IncOakland, California  94609
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Saint Margaret's HospitalSpring Valley, Illinois  61362
Fort Wayne Medical Oncology and Hematology Inc - State BoulevardFort Wayne, Indiana  46845
Lakeland HospitalSt. Joseph, Michigan  49085
Minneapolis Veterans Medical CenterMinneapolis, Minnesota  55417
Lincoln Medical Education Foundation Cancer Resource CenterLincoln, Nebraska  68510
Missouri Valley Cancer Consortium CCOPOmaha, Nebraska  68106
New Hampshire Oncology Hematology AssociatesHooksett, New Hampshire  03106
LRGHealthcare-Lakes Region General HospitalLaconia, New Hampshire  03246
Cooper Hospital University Medical CenterCamden, New Jersey  08103
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Jupiter Medical CenterJupiter, Florida  33458
Gainesville Hematology Oncology AssociatesGainesville, Florida  32605
Elkhart ClinicElkhart, Indiana  46515
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
Illinois CancerCare-BloomingtonBloomington%, Illinois  61701
Illinois CancerCare-CantonCanton, Illinois  61520
Illinois CancerCare-CarthageCarthage, Illinois  62321
Illinois CancerCare-EurekaEureka, Illinois  61530
Illinois CancerCare-HavanaHavana, Illinois  62644
Illinois CancerCare-Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare-MacombMacomb, Illinois  61455
Illinois CancerCare-MonmouthMonmouth, Illinois  61462
Illinois CancerCare-Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare-PekinPekin, Illinois  61603
Illinois CancerCare-PeruPeru, Illinois  61354
Illinois CancerCare-PrincetonPrinceton, Illinois  61356
Illinois CancerCare-Spring ValleySpring Valley, Illinois  61362
Michiana Hematology Oncology PC-ElkhartElkhart, Indiana  46514
Michiana Hematology Oncology PC-PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
Michiana Hematology Oncology-PC WestvilleWestville, Indiana  46391
Michiana Hematology Oncology PC-NilesNiles, Michigan  49120
University of Missouri - Ellis FischelColumbia, Missouri  65203
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
FirstHealth of the Carolinas-Moore Regional HosiptalPinehurst, North Carolina  28374
Palchak David MDPismo Beach, California  93449
Beaufort Memorial HospitalBeaufort, South Carolina  29902
Michiana Hematology Oncology PC-MishawakaMishawaka, Indiana  46545-1470
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Hematology Oncology Associates of Central New York PCEast Syracuse, New York  13057
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718