None listed
Conditions
Interventions
This is an open-label, randomized Phase II study of HyCAMP versus irinotecan as second-line or subsequent-line treatment for metastatic colorectal cancer, for patients who have previously received 5-FU based chemotherapy. The mixture of HA and irinotecan will be given by intravenous infusion on day 1 of a 3-week cycle, up to a maximum of 8 cycles, with the control arm receiving irinotecan alone in the same treatment schedule. The treatment dose of HyCAMP has been shown to be safe in a recently c
This is an open-label, randomized Phase II study of HyCAMP versus irinotecan as second-line or subsequent-line treatment for metastatic colorectal cancer, for patients who have previously received 5-FU based chemotherapy. The mixture of HA and irinotecan will be given by intravenous infusion on day 1 of a 3-week cycle, up to a maximum of 8 cycles, with the control arm receiving irinotecan alone in the same treatment schedule. The treatment dose of HyCAMP has been shown to be safe in a recently completed Phase I study combining irinotecan with HA. Patients will be randomized in a 1:1 fashion to either 1) HyCAMP (irinotecan and HA) or 2) Control arm (irinotecan)
Sponsors
Meditech Research Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients may be included in the study only if they meet ALL of the following criteria:- Diagnosis of locally advanced or metastatic colorectal cancer and present or past histologic documentation of adenocarcinoma of the colon or rectum.- Failure of previous fluorouracil (or capecitabine) based chemotherapy, defined as progression following fluorouracil-based chemotherapy for metastatic disease, or within 6 months following completion of adjuvant fluorouracil-based chemotherapy.- At least one measurable lesion must be present.- ECOG performance status 0 or 1.- Predicted life expectancy greater than 12 weeks.- Adequate major organ function defined as follows: Bone marrow: Neutrophil count greater than 1.5 x 109/l Platelet count greater than 100 x 109/l Hepatic: Serum bilirubin less than 1.25 x ULN ALT less than 5.0 x ULN Renal: Creatinine less than 0.2 mmol/l.- Patient accessible for treatment and follow-up.- Written informed consent.
Exclusion criteria
Patients will be excluded from the study for ANY of the following reasons:- Previous exposure to irinotecan (prior oxaliplatin is permitted).- Active inflammatory bowel disease or any chronic diarrhoea greater than Grade 2.- Cerebral metastases.- Bulky disease (>50% hepatic involvement, >25% lung involvement, or abdominal mass greater than 10 cm) due to an increased risk of toxicity.- Radiotherapy within the preceding 4 weeks, unless to a single bone site.- Radiotherapy to > 30% of bone marrow.- Prior radiotherapy to the pelvis.- Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis.- Patients with Gilberts syndrome.- Patients receiving treatment with phenobarbitone, St John Wort, phenytoin or valproate.- Partial or complete bowel obstruction.- Concomitant active infection. - Currently active second malignancy, other than non-melanoma skin cancers.- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with interpretation of study results. - Pregnant or lactating women or women of childbearing potential not using adequate contraception.
Outcome results
None listed