ClinicalTrials.Veeva

Menu

Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer

Dana-Farber Cancer Institute logo

Dana-Farber Cancer Institute

Status and phase

Completed
Phase 2

Conditions

Gastric Cancer
Esophageal Cancer
GE Junction Cancer

Treatments

Drug: Irinotecan
Drug: Taxotere
Drug: Cisplatin

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and bad) the combination may have on the patients cancer.

Full description

  • 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems