ACTRN12611000520932
Recruiting
Phase 1
A Phase I/IIa trial of HA-Irinotecan, a formulation of hyaluronic acid and irinotecan, in the treatment of extensive stage small cell lung cancer and its effect on tumour stem cells.
Southern Health0 sites40 target enrollmentMay 20, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Southern Health
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must fulfill all of the following criteria to be eligible for admission to the study:
- •18 years of age and older
- •Male or female
- •Histologically or cytologically confirmed small cell lung cancer, that is defined as a previously untreated metastatic or extensive disease:
- •Malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease.
- •Prior radiotherapy allowed.
- •Measurable disease, defined as 1 unidimensionally measurable lesion equal to1 cm by physical examination or radiographic techniques
- •Known brain metastases allowed.
- •Eastern Cooperative Oncology Group(ECOG) performance status 0\-2
- •Life expectancy greater than 3 months
Exclusion Criteria
- •Patients who fulfill any of the following criteria are not eligible for admission to the study:
- •Previous exposure to any chemotherapy for small cell lung cancer
- •Bilirubin greater than 1\.5 mg/dL
- •ECOG greater than 2
- •Active inflammatory bowel disease or any chronic diarrhoea grade 2\.
- •Bulky disease (\>50% hepatic involvement, \>25% lung involvement, or abdominal mass 10 cm) due to an increased risk of toxicity.
- •Radiotherapy within the preceding 4 weeks, unless to a single bone site.
- •Documented unsuitability for irinotecan includes known hypersensitivity to a camptothecin drug, abnormal glucuronidation of bilirubin or Gilbert’s syndrome.
- •Patients receiving treatment with phenobarbitone, St John’s Wort, phenytoin or valproate.
- •Partial or complete bowel obstruction.
Outcomes
Primary Outcomes
Not specified
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