Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000119695
Ethics application status
Approved
Date submitted
8/08/2005
Date registered
10/08/2005
Date last updated
14/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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 (CTA 2004) ............incidence of grade 3 or 4 diarrhoea.
Universal Trial Number (UTN)
Trial acronym
HyCAMP Phase II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic colorectal cancer 207 0
Condition category
Condition code
Cancer 231 231 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 135 0
Treatment: Drugs
Comparator / control treatment
Control arm receiving irinotecan alone
Control group
Active

Outcomes
Primary outcome [1] 278 0
Incidence of Grade 3 and 4 diarrhoea
Timepoint [1] 278 0
Secondary outcome [1] 622 0
Incidence of Grade 3 or 4 neutropenia.
Timepoint [1] 622 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence with blocking, no stratification
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 292 0
Self funded/Unfunded
Name [1] 292 0
Country [1] 292 0
Primary sponsor type
Commercial sector/Industry
Name
Meditech Research Limited
Address
Country
Australia
Secondary sponsor category [1] 223 0
None
Name [1] 223 0
Nil
Address [1] 223 0
Country [1] 223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1147 0
Royal Melbourne Hospital
Ethics committee address [1] 1147 0
Ethics committee country [1] 1147 0
Australia
Date submitted for ethics approval [1] 1147 0
Approval date [1] 1147 0
Ethics approval number [1] 1147 0
Ethics committee name [2] 1148 0
Western Hospital
Ethics committee address [2] 1148 0
Ethics committee country [2] 1148 0
Australia
Date submitted for ethics approval [2] 1148 0
Approval date [2] 1148 0
Ethics approval number [2] 1148 0
Ethics committee name [3] 1149 0
Peter MacCallum Cancer Centre
Ethics committee address [3] 1149 0
Ethics committee country [3] 1149 0
Australia
Date submitted for ethics approval [3] 1149 0
Approval date [3] 1149 0
Ethics approval number [3] 1149 0
Ethics committee name [4] 1150 0
Austin Health
Ethics committee address [4] 1150 0
Ethics committee country [4] 1150 0
Australia
Date submitted for ethics approval [4] 1150 0
Approval date [4] 1150 0
Ethics approval number [4] 1150 0
Ethics committee name [5] 1151 0
Southern Health
Ethics committee address [5] 1151 0
Ethics committee country [5] 1151 0
Australia
Date submitted for ethics approval [5] 1151 0
Approval date [5] 1151 0
Ethics approval number [5] 1151 0
Ethics committee name [6] 1152 0
Peninsular Health
Ethics committee address [6] 1152 0
Ethics committee country [6] 1152 0
Australia
Date submitted for ethics approval [6] 1152 0
Approval date [6] 1152 0
Ethics approval number [6] 1152 0
Ethics committee name [7] 1153 0
Eastern Health
Ethics committee address [7] 1153 0
Ethics committee country [7] 1153 0
Australia
Date submitted for ethics approval [7] 1153 0
Approval date [7] 1153 0
Ethics approval number [7] 1153 0
Ethics committee name [8] 1154 0
Illawarra Area Health Services
Ethics committee address [8] 1154 0
Ethics committee country [8] 1154 0
Australia
Date submitted for ethics approval [8] 1154 0
Approval date [8] 1154 0
Ethics approval number [8] 1154 0
Ethics committee name [9] 1155 0
Bayside Hospital
Ethics committee address [9] 1155 0
Ethics committee country [9] 1155 0
Australia
Date submitted for ethics approval [9] 1155 0
Approval date [9] 1155 0
Ethics approval number [9] 1155 0
Ethics committee name [10] 1156 0
Border Medical Oncology
Ethics committee address [10] 1156 0
Ethics committee country [10] 1156 0
Australia
Date submitted for ethics approval [10] 1156 0
Approval date [10] 1156 0
Ethics approval number [10] 1156 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35384 0
Address 35384 0
Country 35384 0
Phone 35384 0
Fax 35384 0
Email 35384 0
Contact person for public queries
Name 9324 0
Ms Kathy Skoff
Address 9324 0
TOK Corporate Centre
Level 1
459 Toorak Road
Toorak VIC 3142
Country 9324 0
Australia
Phone 9324 0
+61 3 8862 6352
Fax 9324 0
Email 9324 0
[email protected]
Contact person for scientific queries
Name 252 0
Ms Kathy Skoff
Address 252 0
TOK Corporate Centre
Level 1
459 Toorak Road
Toorak VIC 3142
Country 252 0
Australia
Phone 252 0
+61 3 8862 6352
Fax 252 0
Email 252 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.