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Adenocarcinoma of the Gastroesophageal JunctionPhase 2NCT00991952

Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery

A Phase 2 study testing alvocidib, irinotecan hydrochloride and laboratory biomarker analysis in people with Adenocarcinoma of the Gastroesophageal Junction and Diffuse Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
alvocidib, irinotecan hydrochloride and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
5 sitesUnited States
Study dates
Sep 2009to Apr 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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)
  • Tumor must be p53 wild type as defined as =< %20 nuclear staining on immunohistochemistry
  • Women of child-bearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including intrauterine device [IUD], oral contraceptives, or barrier devices) while on treatment and for at least two months after their last treatment on this study; woman also must agree to refrain from nursing during the duration of this study and for at least two months after their last treatment on this study; women of child-bearing potential must have a negative serum pregnancy test to be eligible for this study
  • The patient must have the mental capacity to understand the nature of this study and provide informed consent to participate

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

  • City of Hope

    Duarte, California, 91010

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To examine the antitumor efficacy of irinotecan (irinotecan hydrochloride) followed by flavopiridol (alvocidib) (Arm A) and of irinotecan alone (Arm B) in patients with advanced gastric/ gastroesophageal junction (GEJ) adenocarcinoma wild type for p53.

SECONDARY OBJECTIVES:

  1. To evaluate the safety and toxicity of both study arms in patients with advanced gastric/GEJ adenocarcinoma.

II. To examine other measures of antitumor activity in both study arms, including response rate (in patients with measurable disease) and overall survival.

TERTIARY OBJECTIVES:

  1. To evaluate pre- and post-treatment tumor biopsies for p21 and RAD51 homolog (S. cerevisiae) (Rad51) expression in patients who agree to tumor biopsies (Memorial Sloan-Kettering Cancer Center [MSKCC] and Weill-Cornell only).

II. To explore the response to irinotecan and flavopiridol and to irinotecan alone by deoxyribonucleic acid (DNA) microarray technology on pre- and post-treatment tumor biopsies (MSKCC and Weill-Cornell only).

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

ARM A: Patients receive irinotecan hydrochloride intravenously (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.

ARM B: Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 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.

Being tested
alvocidib, irinotecan hydrochloride, laboratory biomarker analysis
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alvocidibDrug

    Also called FLAVO, flavopiridol, HMR 1275, L-868275

    Given IV

  • irinotecan hydrochlorideDrug

    Also called Campto, Camptosar, CPT-11, irinotecan

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00991952
Study groupRoleWhat they receive
Arm A (irinotecan hydrochloride, alvocidib)ExperimentalPatients 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.
Receives: Drug: alvocidib; Drug: irinotecan hydrochloride; Other: laboratory biomarker analysis
Arm B (irinotecan hydrochloride)Active comparatorPatients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: irinotecan hydrochloride; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Response was determined as indicated in the protocol.

    Measured: From the start of treatment for up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionFeb 2012
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00991952
Sponsor's protocol ID
NCI-2011-03825
Other IDs
NCI-2011-03825, CDR0000655636, MSKCC-8060, 8060, 09-074, 8060, N01CM00038
Status last verified
Dec 2013
First submitted
7 Oct 2009
Last updated
26 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alvocidib, irinotecan hydrochloride and laboratory biomarker analysis in people with Adenocarcinoma of the Gastroesophageal Junction and Diffuse Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: From the start of treatment for up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00991952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.

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