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Esophageal CancerPhase 1NCT00524186

Sunitinib, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal Cancer

A Phase 1 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Esophageal Cancer and Gastric Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or… Read more about this study

Who is it for?
Ages Up to 120 years
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
fluorouracil, irinotecan hydrochloride and leucovorin calcium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
May 2007to Apr 2016
Phase
Phase 1
Are there results?
None posted in the registry

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 Up to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of 1 of the following:
  • Locally advanced or unresectable gastric cancer
  • Metastatic gastric adenocarcinoma
  • Metastatic gastroesophageal junction (GEJ) adenocarcinoma
  • Esophageal adenocarcinomas with involvement of GEJ allowed
  • ECOG performance status 0-1
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  • Life expectancy > 12 weeks
  • WBC ≥ 3,000/μL
  • Platelet count ≥ 100,000/μL
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior chemotherapy for metastatic disease
  • Concurrent therapeutic anticoagulation allowed

Who cannot join

  • Symptomatic, uncontrolled CNS metastases
  • PATIENT CHARACTERISTICS:
  • Uncontrolled infection
  • Uncontrolled serious medical disease
  • Uncontrolled hypertension
  • Coagulopathy or bleeding disorder
Show all 11Show fewer
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate or other agents used in study
  • PRIOR CONCURRENT THERAPY:
  • Other concurrent investigational therapy
  • Concurrent combination antiretroviral therapy in HIV-positive patients
  • Major surgery or radiotherapy within the past 3 weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

Other trials in United States

About this study

Official title: Phase I Study of Sunitinib With FOLFIRI (Irinotecan, 5-Fluorouracil and Leucovorin) for Advanced Gastroesophageal Cancers

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced stomach cancer or gastroesophageal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of sunitinib malate when administered with FOLFIRI chemotherapy comprising irinotecan hydrochloride, fluorouracil, and leucovorin calcium in patients with advanced gastroesophageal cancer.

Secondary

  • Determine the response rates, overall survival, and progression-free survival of patients treated with this regimen.
  • Determine if there is a change in circulating endothelial precursor cell number and VEGF expression as a result of this therapy and if these changes correlate with improved response and survival.
  • Document any pharmacokinetic interactions between irinotecan hydrochloride and sunitinib malate.
  • Study pharmacokinetics of sunitinib malate on day 14 (steady state) and day 42 (after 6 weeks of continuous dosing).

OUTLINE: Patients receive oral sunitinib malate on day -7 and then once daily on days 2-28 in course 1 and on days 1-28 in all subsequent courses. Patients also receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, fluorouracil IV continuously over 46 hours, and leucovorin calcium IV over 2 hours beginning on days 1 and 15. Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Blood is collected at baseline and periodically during study for pharmacokinetic and biomarker correlative studies. Samples are analyzed by flow cytometry to assess circulating endothelial cells and VEGF expression.

After completion of study treatment, patients are followed for 4 weeks.

Keywords
stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the esophagus, stage IV esophageal cancer, recurrent gastric cancer, recurrent esophageal cancer, adenocarcinoma of the stomach
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

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

Study groups in NCT00524186
Study groupRoleWhat they receive
Oral SunitinibExperimentalPatients receive oral sunitinib malate on day -7 and then once daily on days 2-28 in course 1 and on days 1-28 in all subsequent courses
Receives: Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: sunitinib malate; Other: flow cytometry; Other: pharmacological study

What is being measured

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

  1. Maximum tolerated dose of sunitinib malate when administered with FOLFIRI chemotherapy (i.e., irinotecan hydrochloride, fluorouracil, and leucovorin calcium)

    Measured: 30 days after treatment

Secondary outcomes (7)

  1. Toxicity

    Measured: 28 days

  2. Response rate as assessed by RECIST criteria

    Measured: Every 3 months up to 5 years

  3. Progression-free survival

    Measured: Every 3 months up to 5 years

  4. Overall survival

    Measured: up to 5 years

  5. Circulating endothelial precursor cell (CEC) number

    Measured: At baseline

  6. VEGF expression

    Measured: At Baseline

  7. Correlation of pre- and post-therapy changes in CEC number and VEGF expression with response rate and survival

    Measured: Every 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 posted3 Sep 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionAug 2013
  4. Study completionApr 2016

Why it stopped: PI left institute

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00524186
Sponsor's protocol ID
CDR0000562762
Other IDs
RPCI-I-69605
Status last verified
Jun 2016
First submitted
31 Aug 2007
Last updated
21 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Mukherjee S, Fountzilas C, Boland PM, Gosain R, Attwood K, Tan W, Khushalani N, Iyer R. Phase I Study of Irinotecan/5-Fluorouracil/Leucovorin (FOLFIRI) with Sunitinib for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. Target Oncol. 2020 Feb;15(1):85-92. doi: 10.1007/s11523-019-00692-y.

    PubMed 31802410

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Esophageal Cancer and Gastric Cancer, run by Roswell Park Cancer Institute at 1 site 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 16 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was stopped early (reason given: PI left institute). Results are not available in the source record.

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?

Maximum tolerated dose of sunitinib malate when administered with FOLFIRI chemotherapy (i.e., irinotecan hydrochloride, fluorouracil, and leucovorin calcium) (time frame: 30 days after treatment). 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 NCT00524186, which also lists 1 linked publication.

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 21 Jun 2016.

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