None listed
Conditions
Interventions
Chemotherapy: CPT-11, Leucovorin, 5FU. All drugs will be given in repeated six-week courses comprising weekly therapy for four weeks followed by a two-week rest period.
Sponsors
Site - Investigator Initiated . AGITG sponsored trial, conducted through NHMRC CTC
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have clinically documented locally advanced or metastatic adenocarcinoma of the stomach and histologic confirmation of the diagnosis. Patients must have measurable disease (lesions > 1x1 cm by clinical measurement or chest x-ray, and > 2x2 cm by CT or ultrasound). Patients must have a performance status of 0-2 on the ECOG Performance Scale. Patients must have a predicted life expectancy of at least 12 weeks. Patients must have a pre-treatment granulocyte count (ie., segmented neutrophils + bands) of > 1.5 x 109/L, a haemoglobin level of 90 gm/L and a platelet count of > 100 x 109/L. Patients must have adequate renal function as documented by a serum creatinine 200 mol/L. Patients must have adequate hepatic function as documented by a serum bilirubin 25 mol/L, regardless of whether patients have liver involvement secondary to tumour. Aspartate transaminase (AST, SGOT) must be 3x institutional upper limit of normal unless the liver is involved with tumour, in which case the aspartate transaminase must be 5x institutional upper limit of normal. Patients must be and geographically assessable and physically capable of completing study investigations as required. Patients must give written informed consent.
Exclusion criteria
Patients who have previously received CPT-11 or topotecan. Patients who have received chemotherapy in both the neoadjuvant / adjuvant setting and for recurrent/metastatic disease. (Prior chemotherapy is permitted under certain conditions see section 8.1). Patients with any active or uncontrolled infection, including known HIV infection. Patients with psychiatric disorders that would interfere with consent or follow up. Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy. Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least five years. Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Presence of clinically apparent central nervous system metastases or carcinomatous meningitis. Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis are ineligible. Patients with uncontrolled diabetes mellitus, defined as random blood sugar > 15 mmol/L. Patients with baseline serum calcium 2.70 mmol/L. Patients with known Gilbert's Disease, as these patients may have excessive CPT-11-induced toxicity. Patients with any other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study.
Outcome results
None listed