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

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

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Trial Information

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

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

- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.S.C./ Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

February 2006

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



U.S.C. / Norris Comprehensive Cancer Center Los Angeles, California  90033