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Esophageal CancerPhase 2NCT00183807

A Study of Irinotecan, Cisplatin and Celebrex in Patients With Metastatic or Unresectable Esophageal Cancer

A Phase 2 study testing irinotecan, cisplatin, celecoxib in people with Esophageal Cancer, run by University of Southern California 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

This study is for patients with cancer of the esophagus. This study uses the drugs irinotecan, cisplatin and celecoxib. Irinotecan (also known as CPT-11) was recently approved by the U.S. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
irinotecan, cisplatin, celecoxib
How many people
6 participants
Where
1 siteUnited States
Study dates
Oct 2003to Mar 2008
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor. To be unresectable a patient must have been examined by a surgeon and declared unresectable.
  • Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed.
  • Patients must agree to have a sample 20 cc drawn in addition to routine labs with each cycle of chemotherapy.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan. If prior radiation therapy was administered, measurable disease must be outside the radiation field.
  • Patients may have received prior adjuvant chemotherapy; this must have been completed at least 6 months prior to the initiation of therapy for metastatic disease.
  • Patients must have a Zubrod performance status of 0-2.
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  • Patients must have a predicted life expectancy of at least 12 weeks.
  • Patients must have a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of >1,500/mm3, a hemoglobin level of greater than or equal to9.0 gm/dl, and a platelet count of >100,000/mm3.
  • Patients must have adequate renal function as documented by
  • 1) creatinine less than or equal to 1.5 X institutional upper limit of normal OR 2) creatinine clearance > 60 mL/min as calculated with
  • Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to 2x the institutional upper limit of normal, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase (SGOT) must be less than or equal to 3x institutional upper limit of normal, unless the liver is involved with tumor, in which case the aspartate transaminase must be less than or equal to 5x institutional upper limit of normal.
  • No major surgery within 1 month of starting study drug.

Who cannot join

  • Patients who have received prior therapy with CPT-11 or cisplatin as adjuvant therapy less than 12 months prior to initiation of therapy for metastatic disease. All other adjuvant chemotherapy must have been completed at least 6 months prior to entry onto trial.
  • Prior treatment with celebrex, that is if patients are currently using celebrex on a regular basis for the treatment of other disorders, i.e arthritis, etc.
  • Patients who have received prior treatment for metastatic or unresectable disease
  • Patients taking full-dose NSAIDs, including aspirin, regularly for any reason (e.g., arthritis, history of TIA or myocardial infarction). Patients taking cardiac preventive dose ASA (<81mg daily) are eligible. Patients should stop taking any other NSAIDs 14 days prior to receiving first dose of Celecoxib.
  • Patients may not have a history of an allergy to sulfonamide drugs.
  • Patients may not have active peptic ulcer disease or other contraindications to chronic NSAID use or aspirin use.
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  • Patients may not have known lactose intolerance.
  • Patients with any active or uncontrolled infection, including known HIV infection
  • Patients with psychiatric disorders that would interfere with consent or follow-up
  • Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Presence of clinically apparent central nervous system metastases or carcinomatous meningitis
  • Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.
  • Patients with uncontrolled diabetes mellitus, defined as random blood sugar greater than or equal to 200 mg/dl.
  • Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • U.S.C. / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: A Phase II Study of Irinotecan (Camptosar), Cisplatin and Celebrex in Patients With Metastatic or Unresectable Esophageal Cancer

This study is for patients with cancer of the esophagus. This study uses the drugs irinotecan, cisplatin and celecoxib. Irinotecan (also known as CPT-11) was recently approved by the U.S. Food and Drug Administration (FDA) for use in colon cancer, but has not been approved by the FDA for use in the treatment of cancers of the esophagus. Cisplatin is a drug that is commonly used to treat patients with cancer of the esophagus. We are combining these two chemotherapy drugs with a drug called Celebrex. Celebrex (also called Celecoxib) is an oral medication that is approved by the FDA for pain in the treatment of arthritis. There is some information to suggest that this drug may have anti-cancer activity. In prior studies combining irinotecan and cisplatin, tumors of the esophagus have been shown to shrink. We are adding Celebrex to these drugs to see if it makes the drugs work better to shrink cancer or cause fewer side effects.

Being tested
irinotecan, cisplatin, celecoxib
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • irinotecan, cisplatin, celecoxibDrug

What is being measured

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

  1. To assess the time to progression of CPT-11 and cisplatin in combination with celebrex in patients with metastatic or unresectable carcinoma of the esophagus

Secondary outcomes (4)

  1. To assess response rate and overall survival in these patients.

  2. To assess the toxicity of this regimen.

  3. To identify molecular correlates of response and survival (gene expression and genomic polymorphism of enzymes involved in drug metabolism, DNA repair, apoptosis)

  4. To evaluate the effects of celebrex on a variety of histological and molecular biomarkers of angiogenesis, including in vitro activity assays on endothelial cell proliferation, migration and invasion.

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionFeb 2006
  4. Study completionMar 2008

Why it stopped: Insufficient Accrual

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00183807
Sponsor's protocol ID
3E-02-1
Status last verified
May 2014
First submitted
9 Sep 2005
Last updated
22 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan, cisplatin, celecoxib in people with Esophageal Cancer, run by University of Southern California 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 12 inclusion and 14 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 22 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 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 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?

The study was stopped early (reason given: Insufficient Accrual). 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?

To assess the time to progression of CPT-11 and cisplatin in combination with celebrex in patients with metastatic or unresectable carcinoma of the esophagus. 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 NCT00183807.

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 22 May 2014.

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Clinical Trial NCT00183807 | AzTrials