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Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma


Phase 2
N/A
N/A
Open (Enrolling)
Both
Childhood Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer, Type 1 Papillary Renal Cell Carcinoma, Type 2 Papillary Renal Cell Carcinoma

Thank you

Trial Information

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma


PRIMARY OBJECTIVES:

I. To assess the response rate (confirmed complete and partial response) of patients with
locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197
(tivantinib) or ARQ 197 combined with erlotinib (erlotinib hydrochloride).

SECONDARY OBJECTIVES:

I. To assess the progression free survival (PFS) of patients with locally advanced or
metastatic papillary renal cell carcinoma treated with either ARQ 197 or ARQ 197 combined
with erlotinib.

II. To assess the safety and tolerability of ARQ 197 therapy and ARQ 197 combined with
erlotinib.

III. To bank tissue specimens for future use and once funding is obtained to evaluate the
expression of tissue correlative biomarkers such as hepatocyte growth factor receptor
(c-MET) and epidermal growth factor receptor (EGFR), and to perform exploratory correlation
with clinical outcomes.

IV. To descriptively assess the role of prior treatment on outcome.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28.

ARM II: Patients receive tivantinib PO BID and erlotinib hydrochloride PO once daily (QD) on
days 1-28.

In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

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


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed papillary histology
renal cell carcinoma which is metastatic, or locally advanced and unresectable; mixed
histologies will be allowed provided that they contain >= 50% of the papillary
component

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension; x-rays, scans or physical examinations
used for tumor measurement must have been completed within 28 days prior to
registration; x-rays, scans or physical examinations for non-measurable disease must
have been completed within 42 days prior to registration; all disease must be
assessed and documented on the Baseline Tumor Assessment form

- Patients with metastatic disease who have a resectable primary tumor and are deemed a
surgical candidate may have undergone resection; at least 28 days must have elapsed
since surgery and patient must have recovered from any adverse effects of surgery

- Patients with a history of brain metastases who are asymptomatic and have not
received steroid therapy in the 14 days prior to registration are eligible;
anti-seizure medications are allowed provided they are non-enzyme inducing (e.g.
topiramate, levetiracetam, gabapentin)

- Patients may have received up to one prior systemic therapy for advanced or
metastatic renal cell carcinoma; patients must not have received a MET inhibitor or
erlotinib as prior therapy; at least 21 days must have elapsed since completion of
prior systemic therapy, 42 days for nitrosoureas or mitomycin C; patients must have
recovered from all associated toxicities at the time of registration

- Patients may have received prior radiation therapy, but must have measurable disease
outside the radiation port; at least 21 days must have elapsed since completion of
prior radiation therapy; patients must have recovered from all associated toxicities
at the time of registration

- Patients must be offered the opportunity to participate in specimen banking for
future translational medicine studies

- Patients must have a Zubrod performance status of 0-2

- White blood cell (WBC) >= 2,000/mcL

- Absolute neutrophil count (ANC) >= 1,000/mcL

- Platelet count >= 75,000/mcL

- Serum bilirubin =< 1.5 x institutional upper limits of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and
serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) must be =<
1.5 x the institutional ULN unless the liver is involved with the tumor, in which
case serum transaminase (SGOT/SGPT) must be =< 5 x the institutional ULN

- Serum creatinine must be =< 2 x the institutional ULN

- Sodium, potassium and calcium must be obtained within 14 days prior to registration

- Patients with a known history of the following corneal diseases are not eligible: dry
eye syndrome, Sjogren's syndrome, keratoconjunctivitis sicca, exposure keratopathy,
Fuchs' dystrophy or other active disorders of cornea

- Patients known to be human immunodeficiency virus (HIV)-positive and receiving
combination anti-retroviral therapy are not eligible

- Patients must be able to take oral medications; patients must not have
gastrointestinal tract disease resulting in an inability to take oral medication or a
requirement for intravenous (IV) alimentation, prior surgical procedures affecting
absorption, or active peptic ulcer disease; patients with intractable nausea or
vomiting are not eligible

- Patients must not be receiving or planning to receive any other investigational
agents.

- Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method; a woman is considered to be of
"reproductive potential" if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, "effective
contraception" also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate (confirmed complete response [CR] or partial response [PR]), determined according to Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Przemyslaw Twardowski

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01641

NCT ID:

NCT01688973

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Childhood Renal Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Type 1 Papillary Renal Cell Carcinoma
  • Type 2 Papillary Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Loyola University Medical CenterMaywood, Illinois  60153
Rapid City Regional HospitalRapid City, South Dakota  57709
Via Christi Regional Medical CenterWichita, Kansas  67214
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Group Health CooperativeSeattle, Washington  98112
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Grandview HospitalDayton, Ohio  45405
Mercy HospitalCoon Rapids, Minnesota  55433
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Miami Valley HospitalDayton, Ohio  45409
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Greene Memorial HospitalXenia, Ohio  45385
Providence Medical CenterKansas City, Kansas  66112
Hennepin County Medical CenterMinneapolis, Minnesota  
University of RochesterRochester, New York  14642
Glens Falls HospitalGlens Falls, New York  12801
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Wayne State UniversityDetroit, Michigan  48202
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Cancer Center of Kansas - McPhersonMcPherson, Kansas  67460
Columbus CCOPColumbus, Ohio  43206
Wichita CCOPWichita, Kansas  67214-3882
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Lakeview HospitalStillwater, Minnesota  55082
New Ulm Medical CenterNew Ulm, Minnesota  56073
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Good Samaritan Regional Medical CenterMt. Vernon, Illinois  62864
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Saint Louis-Cape Girardeau CCOPSaint Louis, Missouri  63141
Saint John's Mercy Medical CenterSaint Louis, Missouri  63141
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Veterans Adminstration New Jersey Health Care SystemEast Orange, New Jersey  07018-1095
Orange Regional Medical CenterMiddletown, New York  10940
Kinston Medical Specialists PAKinston, North Carolina  28501
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Marietta Memorial HospitalMarietta, Ohio  45750
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Saint Luke's South HospitalOverland Park, Kansas  66213
Kansas City CCOPPrairie Village, Kansas  66208
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Saint Joseph Oncology IncSaint Joseph, Missouri  64507
The Mark H Zangmeister CenterColumbus, Ohio  43219
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center-Main CampusBurien, Washington  98166
United General HospitalSedro-Woolley, Washington  98284
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Swedish Cancer Institute-IssaquahIssaquah, Washington  98029
Franciscan St. Francis HealthIndianapolis, Indiana  46237
Southwest Oncology GroupSan Antonio, Texas  78245
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Springfield Regional Medical CenterSpringfield, Ohio  45505
Saint Louis Cancer and Breast Institute-South CitySaint Louis, Missouri  63109
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
Idaho Urologic Institute PAMeridian, Idaho  83642
Hines Veterans Administration HospitalHines, Illinois  60141