colorectal cancer
Conditions
Interventions
Sponsors
NPO Epidemiological and Clinical Research Information Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histopathologically diagnosed colon carcinoma or rectal carcinoma. (2) Advanced or recurrent disease that is not amenable to curative resection. (3) No history of chemotherapy, immunotherapy, or radiotherapy (including palliative local radiation). (4) At least 4 weeks after surgery. (5) ECOG performance status of 0-1. (6) Age between 20 and 80 years (inclusive). (7) Life expectancy of at least 12 weeks. (8) Presence of at least one measurable lesion (outside the radiation field). A measurable lesion is defined as one that can be measured in a single dimension by palpation (together with a scale-containing radiographic image that permits objective assessment of the lesion size), CT, MRI, or any other radiographic method and which has a larger diameter >=2 cm (or >=1 cm and >=twice the slice width when measured by MRI or spiral CT). (9) Adequate function of vital organs (e.g., bone marrow, heart, lungs, liver, and kidneys), as demonstrated by laboratory data obtained within 14 days of enrollment that are in the following ranges: White blood cell count: 3,000-12,000/mm3. Neutrophil count: >=1,500/mm3 (calculated from the white blood cell count and the differential neutrophil count [%]). Platelet count: >=100,000/mm3. Serum bilirubin: =<1.50 mg/dL. AST and ALT: =<100 IU/L or 100 U/L. Serum creatinine: =<1.20 mg/dL. (10) Personally signed and dated written informed consent to participation in this study (including submission of biological specimens) prior to enrollment.
Exclusion criteria
Exclusion criteria: (1) Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment. (2) A history of severe drug allergy. (3) Pleural effusion, ascites, or pericardial effusion requiring drainage. (4) Concurrent active (e.g., clinically significant) infection. (5) Confirmed or clinically suspected brain metastasis.*1 (6) Involvement of the central nervous system. (7) Presence of bone metastasis as the sole metastasis. (8) Any other concurrent malignancy, excluding metachronous malignancy that has been confirmed to have been cured.*2 (9) Uncontrolled hypercalcemia. (10) Uncontrolled hypertension (despite antihypertensive medication). (11) Uncontrolled diabetes mellitus. (12) Any significant electrocardiographic abnormality or clinically significant heart disease.*3 (13) Fresh gastrointestinal bleeding. (14) Intestinal paralysis or obstruction. (15) Diarrhea (watery stools).*4 (16) Positivity for HIV antibody. (17) Current treatment with atazanavir sulfate. (18) Current treatment with phenytoin, warfarin potassium, or flucytosine. (19) Pregnant or breast-feeding women, women of childbearing potential, women who wish to become pregnant, or men who wish to have a child with their female partners. (20) Current participation in any other clinical trial/study. (21) Any other condition that disqualifies the patient from the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)response rate (2)incidence and severity of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Determination of the time to response, the duration of response, the progression-free survival (PFS) time, and the overall survival (OS) time. (2) Evaluation of the causal relationship of each adverse event with the protocol treatment, its reversibility, its cumulative dose-response relationship, and its course over time. (3) Detection of genetic variation (when possible) and correlation of genetic variations with the pharmacokinetics of CPT-11, SN-38, and SN-38G as well as with the toxicities of CPT-11 (as an ancillary investigation). | — |
Countries
Japan
Contacts
Public ContactMai Hatta
Nagoya University Graduate School of Medicine Young Leaders&#39;Program
Outcome results
None listed