Unresectable, locally advanced or metastatic adenocarcinoma of the biliary tract Classification code 10004594
Conditions
Interventions
Product Name: OSI-7904L
Product Code: OSI-7904L
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: OSI-7904
Other descriptive name: Thymidylate synthase inhibitor
Concentration unit: mg/m
Sponsors
OSI Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically (if by fine needle aspirate) documented locally advanced or metastatic adenocarcinoma of the biliary tract (gallbladder, intrahepatic, perihilar or distal extrahepatic tumors). 2. At least 1 target lesion = 20 mm (or = 10 mm on spiral CT-scan). If indicator lesions are in a previously irradiated field, only a clear disease progression of the irradiated lesion or a new lesion in the previously irradiated field will be accepted. 3. Age = 18 years. 4. ECOG Performance Status 0 – 2. 5. Predicted life expectancy = 12 weeks. Patients may have had prior therapy providing the following conditions are met: 6. Chemotherapy: No prior chemotherapy is permitted for locally advanced or metastatic disease. Use of prior chemotherapy in the adjuvant and/or neo-adjuvant setting or as part of a radiosensitization protocol is permitted, provided that the minimum time from completion of such treatment to study entry is at least 12 months. 7. Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of bone marrow reserve provided that they have recovered from the acute, toxic effects of radiotherapy prior to registration. A minimum of 21 days must have elapsed between the end of radiotherapy and registration onto the study (minimum of 28 days for brain metastases). 8. Surgery: Prior surgery is permitted, provided that adequate recovery or wound healing has occurred prior to registration. 9. Adequate baseline bone marrow, hepatic and renal function, defined as follows: •neutrophils =1.5 x 10 (to the power)9/L and platelets =100 x 10 (to the power)9/L. •bilirubin =1.5 x upper limit of the normal range (ULN). •AST and/or ALT 2.5 x ULN (up to 5 x ULN acceptable if liver metastases present). •serum creatinine =1.5 x ULN. 10. Patients must be accessible for repeat dosing and follow-up. 11. Patients must give written informed consent to participate in the study. The provision of a blood sample for genotype profiling is optional and additional consent is required for patients agreeing to this procedure. 12. Patients, both males and females, with reproductive potential (i.e., menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Concurrent anticancer therapy or any other investigational agents while on study. 2. History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer or malignancy from which the patient has been disease-free for at least 3 years. 3. Pregnant or lactating women. 4. Known hypersensitivity to systemic liposomal formulations or to any drug chemically related to OSI-7904L or to 5-FU/LV. 5. Symptomatic brain metastases which are not stable, are not adequately controlled with fixed-dose oral steroids, are potentially life threatening or have required radiation within the last 28 days. 6. Patients with active or uncontrolled infections or with serious illnesses or medical conditions. 7. History of any psychiatric condition that might impair the patient’s ability to understand or to comply with the requirements of the study or to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the objective response rates in patients with untreated unresectable, locally advanced or metastatic cancer of the biliary tract who are treated with OSI-7904L or 5-FU/LV. ;Secondary Objective: •To assess the toxicity and tolerability of OSI-7904L •To evaluate the overall survival •To perform exploratory investigation into the correlation of TS genotype and response to treatment •To further evaluate the PK profile of OSI-7904L (in Stage 2 of the study only). ;Primary end point(s): The primary endpoint of this randomized Phase II study is efficacy as measured by objective tumor response. OSI-7904L will be considered ineffective if the response rate is less than 5% and it will be considered worthy of further evaluation if the response rate is at least 20%. | — |
Countries
Belgium
Outcome results
None listed