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

This study has been terminated.
(Insufficient Accrual)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183807
First received: September 9, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: irinotecan, cisplatin, celecoxib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Irinotecan (Camptosar), Cisplatin and Celebrex in Patients With Metastatic or Unresectable Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To assess response rate and overall survival in these patients.
  • To assess the toxicity of this regimen.
  • To identify molecular correlates of response and survival (gene expression and genomic polymorphism of enzymes involved in drug metabolism, DNA repair, apoptosis)
  • 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.

Enrollment: 6
Study Start Date: October 2003
Study Completion Date: March 2008
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183807

Locations
United States, California
U.S.C. / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Pfizer
Investigators
Principal Investigator: Syma Iqbal, M.D. U.S.C./ Norris Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183807     History of Changes
Other Study ID Numbers: 3E-02-1
Study First Received: September 9, 2005
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Irinotecan
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014