Combined Anticancer Treatment of Advanced Colon Cancer

• Status: Terminated
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS) of perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS) and bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis arising from colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Regensburg
• Collaborator: Heinrich-Heine University, Duesseldorf
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Synchronous or metachronous peritoneal carcinomatosis arising from histologically proven colorectal or appendiceal adenocarcinoma

• Complete macroscopic cytoreduction (CCR-0/1)

• Free treatment interval of at least 6 month after the last chemotherapy

• Age over 18 and below 71 years

• Good general health status (Karnofsky > 70%, ECOG 0-2)

• Absence of hematogenous metastasis (lung, bone, brain, > 3 peripheric resectable liver metastases)

• Absence of contraindication for systemic chemotherapy and/or extended surgery

• Life expectancy greater than 6 months

• Written informed consent

• Creatinine clearance > 50 ml/min, serum creatinine ≤ 1.5 x ULN

• Serum bilirubin ≤ 1.5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2.5 x ULN

• Platelet count > 100,000 /ml, haemoglobin > 9 g/dl, neutrophile granulocytes ≥ 1,500 /ml, International Normalized Ration (INR) ≤ 2

• Absence of peripheral neuropathy > grade 1 (CTCAE v4.0)

• No pregnancy or breast feeding. Adequate contraception in fertile patients.

Exclusion Criteria:

• Incomplete cytoreduction

• Hematogenous metastasis including irresectable liver metastasis

• Prior chemotherapy or therapy with EGFR receptor antibody for metastatic disease

• K-ras mutation

• Known allergy to murine or chimeric monoclonal antibodies

• Histology of signet ring carcinoma

• Other malignancy than disease under study / second cancer

• Impaired liver, renal or hematologic function as mentioned above (inclusion criteria)

• Heart failure NYHA ≥ 2 or significant Coronary Artery Disease

• Alcohol and/or drug abuse

• Patients unable or unwilling to comply with the study protocol, treatment or follow-up

• Patients included in other clinical trials interfering with the present study