A Study of Irinotecan, Cisplatin and Celebrex in Patients With Metastatic or Unresectable Esophageal Cancer
NCT00183807
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Columbus, Ohio
- New York, New York
- Norwalk, Connecticut
- Lewes, Delaware
- Newark, Delaware
- Washington, District of Columbia
- Aurora, Illinois
- Bloomington, Illinois
- Canton, Illinois
- Carthage, Illinois
- Chicago, Illinois
- Decatur, Illinois
- Eureka, Illinois
- Evanston, Illinois
- Galesburg, Illinois
- Galesburg, Illinois
- Harvey, Illinois
- Havana, Illinois
- Hopedale, Illinois
- Joliet, Illinois
- Macomb, Illinois
- Normal, Illinois
- Normal, Illinois
- Ottawa, Illinois
- Ottawa, Illinois
- Pekin, Illinois
- Peoria, Illinois
- Peoria, Illinois
- Peoria, Illinois
- Peoria, Illinois
- Peoria, Illinois
- Peru, Illinois
- Princeton, Illinois
- Rockford, Illinois
- Spring Valley, Illinois
- Springfield, Illinois
- Urbana, Illinois
- Urbana, Illinois
- Elkhart, Indiana
- Fort Wayne, Indiana
- Indianapolis, Indiana
- Indianapolis, Indiana
- Kokomo, Indiana
- La Porte, Indiana
- Michigan City, Indiana
- South Bend, Indiana
- South Bend, Indiana
- South Bend, Indiana
- South Bend, Indiana
- Ames, Iowa
- Bettendorf, Iowa
- Cedar Rapids, Iowa
- Cedar Rapids, Iowa
- Des Moines, Iowa
- Des Moines, Iowa
- Des Moines, Iowa
- Des Moines, Iowa
- Des Moines, Iowa
- Des Moines, Iowa
- Des Moines, Iowa
- Iowa City, Iowa
- Mason City, Iowa
- Ottumwa, Iowa
- Sioux City, Iowa
- Sioux City, Iowa
- Sioux City, Iowa
- West Des Moines, Iowa
- Anthony, Kansas
- Chanute, Kansas
- Dodge City, Kansas
- El Dorado, Kansas
- Fort Scott, Kansas
- Independence, Kansas
- Kingman, Kansas
- Lawrence, Kansas
- Liberal, Kansas
- Newton, Kansas
- Overland Park, Kansas
- Parsons, Kansas
- Pratt, Kansas
- Salina, Kansas
- Shawnee Mission, Kansas
- Wellington, Kansas
- Wichita, Kansas
- Wichita, Kansas
- Wichita, Kansas
- Wichita, Kansas
- Wichita, Kansas
- Winfield, Kansas
- Bangor, Maine
- Baltimore, Maryland
- Easton, Maryland
- Elkton MD, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Burlington, Massachusetts
- South Weymouth, Massachusetts
- Springfield, Massachusetts
- Ann Arbor, Michigan
- Ann Arbor, Michigan
- Dearborn, Michigan
- Escanaba, Michigan
- Flint, Michigan
- Flint, Michigan
- Grosse Pointe Woods, Michigan
- Iron Mountain, Michigan
- Jackson, Michigan
- Kalamazoo, Michigan
- Kalamazoo, Michigan
- Kalamazoo, Michigan
- Lansing, Michigan
- Livonia, Michigan
- Pontiac, Michigan
- Port Huron, Michigan
- Saginaw, Michigan
- Saint Joseph, Michigan
- St. Joseph, Michigan
- Warren, Michigan
- Burnsville, Minnesota
- Coon Rapids, Minnesota
- Duluth, Minnesota
- Duluth, Minnesota
- Duluth, Minnesota
- Edina, Minnesota
- Fridley, Minnesota
- Hutchinson, Minnesota
- Lichfield, Minnesota
- Maplewood, Minnesota
- Maplewood, Minnesota
- Minneapolis, Minnesota
- Minneapolis, Minnesota
- Minneapolis, Minnesota
- Robbinsdale, Minnesota
- Saint Louis Park, Minnesota
- Saint Louis Park, Minnesota
- Saint Paul, Minnesota
- Shakopee, Minnesota
- St. Paul, Minnesota
- Waconia, Minnesota
- Woodbury, Minnesota
- Independence, Missouri
- Kansas City, Missouri
- Kansas City, Missouri
- Kansas City, Missouri
- Kansas City, Missouri
- Kansas City, Missouri
- Kansas City, Missouri
- Kansas City, Missouri
- Liberty, Missouri
- Saint Joseph, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Omaha, Nebraska
- Omaha, Nebraska
- Omaha, Nebraska
- Omaha, Nebraska
- Omaha, Nebraska
- Las Vegas, Nevada
- Las Vegas, Nevada
- Lebanon, New Hampshire
- Marlton, New Jersey
- Newark, New Jersey
- Sparta, New Jersey
- Voorhees, New Jersey
- Voorhees, New Jersey
- Bronx, New York
- Buffalo, New York
- East Syracuse, New York
- Glens Falls, New York
- New York, New York
- New York, New York
- Chapel Hill, North Carolina
- Charlotte, North Carolina
- Goldsboro, North Carolina
- Hendersonville, North Carolina
- Kinston, North Carolina
- Akron, Ohio
- Canton, Ohio
- Cleveland, Ohio
- Columbus, Ohio
- Lima, Ohio
- Allentown, Pennsylvania
- Bethlehem, Pennsylvania
- Danville, Pennsylvania
- East Stroudsburg, Pennsylvania
- Hazleton, Pennsylvania
- Hershey, Pennsylvania
- Lewistown, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Scranton, Pennsylvania
- State College, Pennsylvania
- State College, Pennsylvania
- Wilkes-Barre, Pennsylvania
- Wilkes-Barre, Pennsylvania
- Williamsport, Pennsylvania
- Florence, South Carolina
- Sioux Falls, South Dakota
- Sioux Falls, South Dakota
- Sioux Falls, South Dakota
- Kingsport, Tennessee
- Temple, Texas
- Berlin, Vermont
- Burlington, Vermont
- Danville, Virginia
- Norton, Virginia
- Eau Claire, Wisconsin
- Eau Claire, Wisconsin
- Green Bay, Wisconsin
- Green Bay, Wisconsin
- Green Bay, Wisconsin
- Green Bay, Wisconsin
- Marinette, Wisconsin
- Marshfield, Wisconsin
- Milwaukee, Wisconsin
- Minocqua, Wisconsin
- Oconto Falls, Wisconsin
- Rhinelander, Wisconsin
- Rice Lake, Wisconsin
- Stevens Point, Wisconsin
- Sturgeon Bay, Wisconsin
- Wausau, Wisconsin
- Wausau, Wisconsin
- Weston, Wisconsin
- Wisconsin Rapids, Wisconsin
- Ottawa, Ontario
- Toronto, Ontario
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Study of Irinotecan, Cisplatin and Celebrex in Patients With Metastatic or Unresectable Esophageal Cancer | |||
Official Title ICMJE | A Phase II Study of Irinotecan (Camptosar), Cisplatin and Celebrex in Patients With Metastatic or Unresectable Esophageal Cancer | |||
Brief 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. 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Esophageal Cancer | |||
Intervention ICMJE | Drug: irinotecan, cisplatin, celecoxib | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 6 | |||
Original Enrollment ICMJE | 65 | |||
Actual Study Completion Date ICMJE | March 2008 | |||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00183807 | |||
Other Study ID Numbers ICMJE | 3E-02-1 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Southern California | |||
Study Sponsor ICMJE | University of Southern California | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | University of Southern California | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |