Status:
COMPLETED
Pantoprazole With Doxorubicin for Advanced Cancer Patients With Extension Cohort of Patients With Solid Tumours
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Advanced Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a single-centre, open label, dose finding, phase I study to determine the recommended phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in patients with advanced tumours...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically proven advanced solid tumours for whom no standard anticancer therapy exists
- Measureable and non-measureable disease are both eligible, but disease must be evaluable as defined by RECIST 1.1.
- Patients \>18 years old
- At least 21 days since last chemotherapy regimen and/or radiotherapy
- Recovery from all reversible adverse events of previous anticancer therapies to baseline or to grade \< or =1, except for alopecia.
- Patients must have documented evidence of disease progression on prior systemic therapy.
- ECOG Performance Status of 0 or 1
- Adequate cardiovascular function and no history of serious cardiac diseases (see Exclusion criteria for definition) Left ventricular ejection fraction \> 50% by multi-gated nuclear angiogram
- Patient consent must be obtained according to Institutional REB requirements. The patient must sign the consent form prior to registration.
- Patients must be accessible for treatment and follow-up.
- Previous Therapy
- Chemotherapy: Patients can have had limited exposure to prior anthracyclines defined as no more than a total dose of 240 mg/m2 of doxorubicin or 300 mg/m2 of epirubicin (e.g. as received in the AC x 4 or FEC x 3 adjuvant regimens). Patients with prior exposure to other cardiotoxic anticancer drugs (e.g. mitoxantrone) are not eligible.
- Radiation: Patients may have had prior radiation therapy (including that to the breast or chest wall) provided that has not exceeded 25% of the bone marrow reserve.
- Previous Surgery: Previous surgery is permitted provided that wound healing has occurred.
- Hormonal Therapy: Patients may have had prior hormonal therapy. All hormonal agents must be discontinued at least 3 weeks prior to study entry.
- Laboratory Requirements (must be done within 7 days prior to registration)
- Neutrophil count (ANC) \> or = 1.5 x 10\^9/L
- Hemoglobin \> or = 90 g/L
- Platelet count \> or = 100 x 10\^9/L
- Bilirubin \<1.5 x UNL
- AST or ALT \< or = 2 x UNL
- Creatinine \< or = 1.5 x UNL or creatinine clearance \> or = 50mL/min
Exclusion
- Patients who have previously received more than 240 mg/m2 doxorubicin or 300 mg/m2 epirubicin.
- Patients receiving concurrent treatment with experimental drugs or anti-cancer therapy.
- Patients who are receiving drugs that are known to interact with pantoprazole, including:
- The anti-fungal agents fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;
- The antiviral agents: atazanavir, delavirdine, indinavir, nelfinavir, raltegravir, saquinavir, tipranavir;
- The anticoagulant agents: clopidogrel, dabigatran;
- The immunosuppressive agent: mycophenolate
- The anti-inflammatory agent: mesalamine
- Patients who are receiving oral pantoprazole or other PPI inhibitors may participate if these agents are discontinued at least 7 days before trial entry.
- Patients with untreated brain or meningeal metastases. (MR or CT scans are not required to rule this out unless there is a clinical suspicion of CNS disease). Patients with treated and stable brain metastases are eligible providing that they have radiological evidence of disease stabilization of at least 3 months duration and are asymptomatic.
- Patients who have a history of clinically significant cardiac disease, including:
- Unstable angina/ acute coronary syndrome
- Congestive heart failure
- Myocardial infarction within the past year
- Clinically significant arrhythmia
- Pericarditis or myocarditis
- Symptomatic valvular disease Patients with well-controlled hypertension, uncomplicated mitral valve prolapsed or other stable cardiac conditions are eligible.
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.
- Patients with a known bleeding disorder. Patients who are on stable anticoagulation with warfarin or s.c. heparin products are eligible. Patients receiving clopidogrel are excluded.
- Patients unable or unwilling to give written, informed consent prior to study participation.
- Women who are pregnant or nursing.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01163903
Start Date
July 1 2010
End Date
May 1 2015
Last Update
July 15 2015
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9