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Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Gastric Cancer, Esophageal Neoplasms

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Trial Information

Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

Inclusion Criteria:

- Patients must have clinically documented unresectable or metastatic gastric cancer or
gastroesophageal adenocarcinoma and histologic confirmation of the diagnosis with

- Patients must have received one prior chemotherapeutic regimen for metastatic or
unresectable disease. Patients may not have received prior therapy with irinotecan
or a taxane.

- 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 20 cc blood sample drawn in addition to routine labs
with each cycle of chemotherapy.

- Patients must have measurable disease by clinical exam or radiologic studies, that is
at least one lesion measurable in at least one dimension, measuring 10 mm or more on
a spiral CT scan, or at least 20 mm by an exam or a non-spiral scan. If prior
radiation therapy was administered, measurable disease must be outside the radiation

- 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

- a hemoglobin level of greater than or equal to 9.0 gm/dl, and

- a platelet count of >100,000/mm3.

- Patients must have adequate renal function as documented by a calculated creatinine
clearance > 60.

- Patients must have adequate hepatic function as documented by a serum bilirubin less
than or equal to the institutional upper limit of normal, regardless of whether
patients have liver involvement secondary to tumor.

- No major surgery within 1 month of starting study drug.

- Women of childbearing potential must have a negative pregnancy test.

- Peripheral neuropathy: must be < grade 1

Exclusion Criteria:

- Patients may not have a history of an allergy to irinotecan.

- 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 while on
treatment and for at least 3 months thereafter.

- 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 any other severe concurrent disease, which in the judgment of the
investigator would make the patient inappropriate for entry into this study.

- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80.

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 response rate of patients with metastatic or unresectable adenocarcinoma of the stomach or gastroesophageal junction treated with the combination of irinotecan and docetaxel as second line therapy

Outcome Time Frame:

every 2 cycles

Safety Issue:


Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2005

Completion Date:

January 2015

Related Keywords:

  • Gastric Cancer
  • Esophageal Neoplasms
  • Gastroesophageal cancer
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center Los Angeles, California  90033