NCT00991952

Brief Summary

This randomized phase II trial studies how well giving irinotecan hydrochloride with or without alvocidib works in treating patients with advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery. 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. It is not yet known whether irinotecan hydrochloride is more effective with or without alvocidib.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 21, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 26, 2014

Status Verified

December 1, 2013

Enrollment Period

2.4 years

First QC Date

October 7, 2009

Results QC Date

November 7, 2013

Last Update Submit

May 9, 2014

Conditions

Adenocarcinoma of the Gastroesophageal JunctionDiffuse Adenocarcinoma of the StomachIntestinal Adenocarcinoma of the StomachMixed Adenocarcinoma of the StomachRecurrent Gastric CancerStage IIIA Gastric CancerStage IIIB Gastric CancerStage IIIC Gastric CancerStage IV Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Response was determined as indicated in the protocol.

    From the start of treatment for up to 3 months

Study Arms (2)

Arm A (irinotecan hydrochloride, alvocidib)

EXPERIMENTAL

Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: alvocidibDrug: irinotecan hydrochlorideOther: laboratory biomarker analysis

Arm B (irinotecan hydrochloride)

ACTIVE COMPARATOR

Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: irinotecan hydrochlorideOther: laboratory biomarker analysis

Interventions

alvocidibDRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Arm A (irinotecan hydrochloride, alvocidib)
irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Arm A (irinotecan hydrochloride, alvocidib)Arm B (irinotecan hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Arm A (irinotecan hydrochloride, alvocidib)Arm B (irinotecan hydrochloride)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have pathologically confirmed carcinoma of the stomach or GEJ (Siewert's type I, II, or III); confirmation will be performed locally at each participating institution
  • The patient must have advanced disease not amenable to surgical resection
  • Patients must have disease that can be evaluated radiographically; this may be measurable disease or non-measurable disease; measurable disease is defined as that which can be measured in at least one dimension as \> 20 mm with 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
  • The patient must have received one prior chemotherapy regimen for his or her unresectable or metastatic disease; this does not include therapy administered in the adjuvant or neoadjuvant setting
  • At least 2 weeks must have elapsed since the patient received prior chemotherapy, anti-angiogenic therapy, or other targeted therapy; 2 weeks since prior radiation therapy; or, 4 weeks if the last regimen included carmustine (BCNU) or mitomycin C
  • The patient must have a Karnofsky performance status of \>= 60
  • Serum creatinine =\< 2 mg/dl
  • Total serum bilirubin =\< 2 mg/dl
  • If the patient has Gilbert's disease and has a serum bilirubin greater than 2.0 mg/dl, the case must be discussed with the principal investigator; such a patient may be considered eligible on a case-by-case basis
  • Serum aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 times the upper limit of normal, or
  • Serum AST (SGOT)/ ALT (SGPT) =\< 5 times the upper limit of normal in case of liver metastases
  • White blood cell (WBC) \>= 3000/mm\^3
  • Absolute neutrophil count (ANC) \>= 1000/mm\^3
  • Platelets \>= 75,000/mm\^3
  • The patient must have available tumor tissue for assessment of p53 status by immunohistochemistry (IHC) (=\< 20% cutoff for positivity)
  • +3 more criteria

You may not qualify if:

  • The patient may not have previously received irinotecan or flavopiridol
  • The patient may not be receiving any other investigational agents
  • The patient may not have any ongoing grade 2 or greater toxicity from a prior treatment
  • The patient may not have an ongoing uncontrolled illness including, but not limited to active infection, symptomatic congestive heart failure, myocardial infarction in the past 6 months, or new cardiac arrhythmia in the past 6 months
  • Patients with a diagnosis of active human immunodeficiency virus (HIV) infection, on anti-retroviral therapy, or with a cluster of differentiation 4 (CD4) count less than 200 are ineligible due to potential interactions between irinotecan, flavopiridol, and anti-retroviral medications as well as possible immunosuppressive activity of the study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

alvocidibIrinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Results Point of Contact

Title
Dr. Yelena Janjigian
Organization
Memorial Sloan-Kettering Cancer Center
janjigiy@mskcc.org
646-888-4186

Study Officials

  • Yelena Janjigian

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2012

Study Completion

April 1, 2014

Last Updated

May 26, 2014

Results First Posted

January 21, 2014

Record last verified: 2013-12

Locations

US(5)