A phase ll study of combination therapy with Panitumumab plus CPT-11 for advanced and/or recurrent colon-rectal cancer with wild type KRAS which has prior therapy of fluoropylimidine, oxaliplatin or CPT-11 (OGSG 1001)

A phase ll study of combination therapy with Panitumumab plus CPT-11 for advanced and/or recurrent colon-rectal cancer with wild type KRAS which has prior therapy of fluoropylimidine, oxaliplatin or CPT-11 (OGSG 1001) - A phase ll study of combination therapy with Panitumumab plus CPT-11 for advanced and/or recurrent colon-rectal cancer with wild type KRAS which has prior therapy of fluoropylimidine, oxaliplatin or CPT-11 (OGSG 1001)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003819

Enrollment

Registered

2010-07-15

Start date

2010-07-23

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

colon-rectal cancer

Interventions

One course includes Panitumumab 6mg/kg and Irinotecan 150mg/m2 on day 1 and 14 days rest.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility Criteria 1.Histologically proven colon cancer or rectal cancer except appendical cancer or anal cancer 2.genetically proven KRAS wild type on the tumor tissue 3.with measurable lesions for RECIST criteria 4.patients with tumor resistant/intolerant to oxaliplatin, fluoropyrimidine and/or PD on CPT-11 therapy *resistant/intolerant: PD on the therapy or recurrence within 6 months after the adjuvant therapy. Stop of treatment due to allergic reaction, withdrawal neuro-toxicity and/or other toxic events 5.An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1,or 2. 6.A predicted life expectancy of at least 8 weeks 7.with rest period of treatment a.2 weeks for radiation therapy b.2 weeks for surgical resection c.2 weeks for chemotherapy d.2 weeks for hormone therapy and/or immune therapy e.2 weeks for cytokine therapy and/or BRM therapy 8. with a good condition of important organs a.neutrophil >= 1,000/mm3 b.platelet >= 100,000/mm3 c.ALT/AST <= 2.5 times of normal limit d.total bilirubin <= 1.5mg/dl e.creatinine <= 2.0mg/dl 9. Written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. with symptom of brain metastasis 2.diarrhea (watery stool) 3.intestinal paralysis and/or obstruction 4.with infectious diseases or febrile condition 5.with severe pulmonary diseases (interstitial pneumonitis, pulmonary fibrosis or severe pneumothorax) 6.with severe diseases (uncontrollable DM, heart failure severe than NYHA II, renal failure, and/or liver dysfunction) 7.ladies pregnant and/or nursing baby, or ladies who have plans to have babies. 8.with carcinomatous menigitis, uncontrollable spasms (continuous spasms due to epilepsy) and/or history of mental disorder 9.with grade 3 neural disorder 10.administration of contraindicative medicines 11.history of grade 3 allergy due to CPT-11 12.history of administration of antagonisms to EGF signal and/or anti-EGFR medicines 13.any other patient whom the physician in charge of the study judges to be unsuitable

Design outcomes

Primary

Measure	Time frame
Responce rate(RECIST)	—

Secondary

Measure	Time frame
Disease control rate (CR+PR+SD/ FAS) Progression free survival overall survival Time to progression Adverse events Biomarkers on the specimen pharmakokinetics	—

Countries

Japan

Contacts

Public ContactHiroshi Furukawa

Kinki University School of Medicine Department of surgery

hiroshi.furukawa@tokushukai.jp072-366-0221

Outcome results

None listed

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