A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer (OGSG 0406)

A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer (OGSG 0406) - OGSG 0406

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000766

Enrollment

Registered

2007-07-13

Start date

2004-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced/recurrent colorectal cancer

Interventions

Agents dose rout day l-LV 200mg/m2 div(2 hours) day 1 5-FU 400mg/m2 iv(5 min) day 1 5-FU Xmg/m2 civ(46 hours) day 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. histologically proven colon cancer 2. Age: 20-75 yo 3. Performance status: 0-1 (ECOG criteria) 4. without any prior chemotherapy or with longer than 4 weeks of no-therapy period after prior chemotherapy 5. with sufficient bone marrow, renal or hepatic function Hemoglobin 8.0 g/dl <= WBC: 4,000 /mm3 <= and =< 12,000/mm3 Neutrocyte: 2,000/mm3=< Platelet: 100,000/mm3 =< Total bilirubin: within normal range of each hospital GOT, GPT: within 2 times of normal limit of each hospital Creatinin: within normal range CRP: 2mg/dl => BUN: <= 25mg/dl alb: >=3g/dl cardiac function: tolereble to the regimen of this study 6. without hepatitis virus infection (HBs Ag, HCV Ab) 7. expected survival period longer than 3 months 8. written informed consent

Exclusion criteria

Exclusion criteria: 1.with severe bone marrow suppression 2.with a severe infection 3.with severe cardiac disease 4.with some other severe diseases 5.under a poor general condition 6.under diarrhea which continues more than three days 7.with double cancers which were treated within recent 5 years except carcinoma in situ. 8.with familial polyposis or hereditary disease 9.under pregnancy or nursing 10.with a history of allergic response to Levoholinate or fluorouracil 11.re-registration to this study 12.doctors' decision not to register

Design outcomes

Primary

Measure	Time frame
DLT, MTD, RD	—

Secondary

Measure	Time frame
Feasibility	—

Countries

Japan

Contacts

Public ContactFurukawa Hiroshi

Sakai City Hospital Director

072-221-1700

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026