Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:September 2009

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A Multicenter Random Assignment Phase II Study of Irinotecan and Alvocidib (Flavopiridol) Versus Irinotecan Alone for Patients With p53 Wild Type Gastric Adenocarcinoma


RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Alvocidib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Giving irinotecan hydrochloride together with alvocidib may kill
more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving irinotecan hydrochloride
with or without alvocidib works in treating patients with advanced stomach cancer or
gastroesophageal junction cancer.


OBJECTIVES:

Primary

- To examine the antitumor efficacy of irinotecan hydrochloride with vs without alvocidib
in patients with p53 wild type advanced gastric or gastroesophageal junction
adenocarcinoma.

Secondary

- To evaluate the safety and toxicity of these regimens in these patients.

- To examine other measures of antitumor activity of these regimens, including response
rate (in patients with measurable disease) and overall survival.

Tertiary

- To evaluate pre- and post-treatment tumor biopsy samples for p21 and Rad51 expression
in patients who agree to undergo tumor biopsies (Memorial Sloan-Kettering Cancer Center
[MSKCC] only).

- To explore the response to these regimens by DNA microarray technology using pre- and
post-treatment tumor biopsy samples (MSKCC only).

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

- Arm I: Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV
over 1 hour on days 1 and 8.

- Arm II: Patients receive irinotecan hydrochloride IV over 30 minutes on days 1 and 8.

In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

Tumor tissue samples may be collected pre- and post-treatment for correlative laboratory
studies.

After completion of study treatment, patients are followed up every 3 months for 1 year.

DISEASE CHARACTERISTICS:

- Pathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
(Siewert type I, II, or II)

- Advanced disease not amenable to surgical resection

- Tumor tissue must be available for assessment of p53 status (an additional tumor
biopsy is required if there is not sufficient primary tumor tissue available for
microdissection under high power microscopy, DNA extraction, and sequencing for p53
mutations)

- Tumor must be p53 wild type, defined as ≤ 20% nuclear staining on IHC

- Radiographically evaluable disease (measurable or non-measurable disease)

- Measurable disease is defined as that which can be measured in ≥ 1 dimension as
> 20 mm by conventional techniques or > 10 mm by high-resolution imaging

- Disease that is identified on radiology studies but does not meet the criteria
for measurable disease is considered non-measurable disease

- Must have received 1 prior chemotherapy regimen for unresectable or metastatic
disease (not including treatment administered in the adjuvant and/or neoadjuvant
setting)

- No known CNS metastasis

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- WBC ≥ 3,000/mm^3

- ANC ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3

- Serum creatinine ≤ 2 mg/dL

- Total serum bilirubin ≤ 2.0 mg/dL

- Patients with a serum bilirubin > 2.0 mg/dL who have Gilbert disease may be
eligible on a case-by-case basis after discussion with the principal
investigator

- Serum AST and ALT ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN in the case of
liver metastases)

- CD4 count > 200/mm^3

- Not pregnant or nursing during and for ≥ 2 months after completion of study treatment

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 2 months after
completion of study treatment

- Has the mental capacity to understand the nature of this study and provide informed
consent

- No ongoing toxicity ≥ grade 2 from prior treatment

- No ongoing uncontrolled illness including, but not limited to, any of the following:

- Active infection

- Symptomatic congestive heart failure

- Myocardial infarction within the past 6 months

- New cardiac arrhythmia within the past 6 months

- No diagnosis of active HIV infection

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior irinotecan hydrochloride or alvocidib

- At least 2 weeks since prior chemotherapy (4 weeks if the last regimen included
carmustine or mitomycin C), antiangiogenic therapy, other targeted therapy, or
radiotherapy

- No other concurrent investigational agents

- No concurrent antiretroviral therapy
We found this trial at
24
sites
11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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5841 S Maryland Ave # Mc1140
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Cancer Research Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Chicago, IL
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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500 University Drive
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Penn State Milton S....
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Hershey, PA
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1275 York Avenue
New York, New York 10065
212-639-2000
Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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1300 York Avenue # A421
New York, New York 10065
New York Weill Cornell Cancer Center at Cornell University Welcome to the Division of Hematology...
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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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Beverly Hills, California 90211
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2300 N. Edward Street
Decatur, Illinois 62526
217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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2650 Ridge Ave.
Evanston, Illinois 60201
847.570.2000
Evanston Hospital Evanston Hospital, opened in 1891, is the nucleus of the NorthShore University HealthSystem....
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One Ingalls Drive
Harvey, Illinois 60426
708.333.2300
Ingalls Cancer Care Center at Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare...
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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New York, New York 10016
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Pasadena, California 91105
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8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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607 S. New Ballas Road
Saint Louis, Missouri 63141
(314) 251-4800
David C. Pratt Cancer Center at St. John's Mercy Many forms of cancer are more...
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Springfield, Illinois 62701
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315 West Carpenter Street
Springfield, Illinois 62794
217.545.8000
Simmons Cooper Cancer Institute Simmons Cancer Institute at SIU practices "the team approach" to cancer...
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