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Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan


Phase 1
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma, Gastric Cancer

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Trial Information

Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan


Inclusion Criteria:



- Histologically confirmed recurrent, metastatic, or residual cancer with disease
confined mostly to the peritoneal cavity. Patients with asymptomatic
extra-peritoneal disease are eligible.

- Measurable or evaluable disease. Patients with malignant ascites or carcinomatosis
only (documented by cytology or during surgery) are eligible. Patients with ovarian
cancer and disease manifested only by an elevated CA-125 are also eligible.

- Adequate hepatic, renal, and bone marrow functions: bilirubin less than or equal to
2.0 mg/dl; creatinine less than or equal to 2.0 mg/dl, alkaline phosphatase less
than or equal to 3 x upper limit of normal (uln), AST or ALT less than or equal to 3
x uln; AGC greater than or equal to 1500, platelets greater than or equal to 100,000.

- SWOG performance status 0-2

- Fully recovered from acute toxicities from prior surgery, chemotherapy, or radiation
therapy.

- Patients must use an approved method of birth control.

Exclusion Criteria:

- Medical, social, or psychological factors which could prevent patient from receiving
treatment.

- Prior therapy with intra-peritoneal irinotecan

- Significant intra-peritoneal adhesions detected clinically or by prior surgical
exploration

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks.

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.S.C. / Norris Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

0C-99-7

NCT ID:

NCT00183859

Start Date:

September 1999

Completion Date:

April 2009

Related Keywords:

  • Adenocarcinoma
  • Gastric Cancer
  • solid tumor
  • phase I
  • phase one
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

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