Randomised Phase II trial of irinotecan with hyaluronic acid (HyCAMP) versus irinotecan as treatment for patients with metastatic colorectal cancer who have failed 5-FU based chemotherapy
- Conditions
- Metastatic colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12605000119695
- Lead Sponsor
- Meditech Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 86
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Grade 3 and 4 diarrhoea[]
- Secondary Outcome Measures
Name Time Method Incidence of Grade 3 or 4 neutropenia.[]