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A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer, GE Junction Cancer

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Trial Information

A Phase II Trial of Taxotere, Cisplatin, and Irinotecan in Advanced Esophageal and Gastric Cancer


- Taxotere, cisplatin and irinotecan will be administered to the patient once weekly for
2 weeks followed by a one week rest period (1 cycle is 3 weeks).

- Patients will also receive corticosteroids, intravenous hydration and anti-emetic
therapy prior to each treatment.

- A physical exam and bloodwork will be done each week of the treatment and every 2
cycles, reassessment of the tumor by the same imaging method to determine the baseline
size will be conducted.

- Patients will remain on the study unless disease progression or intolerable toxicity
occur.


Inclusion Criteria:



- Histologically confirmed, incurable esophageal or gastric carcinoma (carcinoma =
adenocarcinoma or squamous cell carcinoma)

- Measurable disease > 1cm (longest diameter) by spiral CT scan or > 2cm by other
radiographic technique.

- Lesions must be measurable in at least one dimension.

- Bone lesions, ascites and effusions are not measurable.

- Irradiated lesions are not measurable yet lesions arising in previously irradiated
fields are measurable.

- Age 18+ years.

- ECOG performance status 0 or 1.

- Life expectancy greater than 12 weeks.

- Adequate bone marrow function.

- Adequate renal function: creatinine equal to or less than 1.5 mg/dl.

- SGOT less than 2.5 x institutional upper limit of normal if alkaline phosphatase is
within institutional upper limit of normal.

- Alkaline phosphatase less than 4.0 x upper limit of normal if SGOT is within
institutional upper limit of normal.

- For patients with both SGOT and alkaline phosphatase elevations, SGOT must be less
than 1.5 x institutional upper limit of normal and alkaline phosphatase must be less
2.5 x institutional upper limit of normal. For patients with liver metastases,
however, SGOT may be < 3.0 x institutional upper limit of normal and alkaline
phosphatase may be < 5.0 x institutional upper limit of normal as long as the total
bilirubin is within the institutional upper limit of normal.

Exclusion Criteria:

- No prior chemotherapy (except as part of pre- or post-operative therapy, completed >
1 year prior to start date of this protocol).

- Patients who have received prior pelvic radiation therapy are ineligible. Other
prior radiation therapy, however, is permitted, provided at least 4 weeks have
elapsed since completion of this therapy and the initiation of this protocol.

- No myocardial infarction in the past six months.

- No major surgery in the past three weeks.

- No uncontrolled serious medical or psychiatric illness.

- No uncontrolled diarrhea.

- Patients with a peripheral neuropathy > grade 1 will be excluded.

- Women of childbearing potential must have a negative pregnancy test. Men and women of
childbearing potential must use adequate contraception.

- No clinically apparent central nervous system metastases or carcinomatous meningitis.

- No other active malignancy other than non-melanoma skin cancer or in-situ cervical
carcinoma. A resected cancer (other than in-situ carcinoma) must have demonstrated
no evidence of recurrence for at least 3 years.

- Patients with history of severe hypersensitivity to irinotecan, cisplatin, taxotere
or drugs formulated with polysorbate 80 must be excluded.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the response rate of patients with esophageal or gastric carcinoma to weekly Taxotere, Cisplatin, and Irinotecan (CPT-11).

Outcome Time Frame:

TBD

Safety Issue:

No

Principal Investigator

Peter C. Enzinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

01-140

NCT ID:

NCT00165464

Start Date:

August 2001

Completion Date:

April 2009

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • GE Junction Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • GE Junction
  • Cisplatin
  • Taxotere
  • CPT-11
  • Irinotecan
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Faulkner HospitalJamaica Plain, Massachusetts  02130