A Phase II Single Arm Study to Evaluate the Safety and Efficacy of RAD001 as Monotherapy in Treatment naïve Advanced Cholangiocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Everolimus
- Conditions
- Cholangiocarcinoma
- Sponsor
- Ratchavithi Hospital
- Enrollment
- 40
- Primary Endpoint
- progression free survival in cholangiocarcinoma patients whom treated with everolimus
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to determine whether everolimus is effective in the treatment of patients with advance cholangiocarcinoma.
Detailed Description
Cholangiocarcinoma is one of the most common cause of cancer death in Thailand. Patients with cholangiocarcinoma are often diagnosed at advanced stage. Palliative therapeutic approaches consisting of percutaneous and endoscopic biliary drainage have usually been used for these patients, since there is no effective chemotherapeutic treatment for this type of cancer. Activation of the phosphoinositide-3-kinase (PI3K)/Akt/mTOR signaling pathway is frequently found in cholangiocarcinoma cells. It has been suggested to be a key step leading to the progression of cholangiocarcinoma. In this study, the investigators hypothesize that inhibition of mTOR may be useful in treating cholangiocarcinoma.
Investigators
Kawin Leelawat
Department of Surgery
Ratchavithi Hospital
Eligibility Criteria
Inclusion Criteria
- •Histologic confirmed diagnosis of cholangiocarcinoma.
- •Patients must present with disease not amenable to curative surgery.
- •ECOG performance status of \< 2
- •Patients with at least one measurable lesion at baseline as per the RECIST criteria.
- •The following laboratory parameters at screening (visit 1):
- •WBC are equal to or more than 3,000/uL. Platelet are equal to or more than 100,000/uL Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN. Patients with known liver metastases: AST and ALT ≤ 5 x ULN Total Bilirubin \< 2 mg/dl\* (after drainage) Serum creatinine equal to or less than 2.0 x upper normal limit
- •Life expectancy equal to or more than 12 weeks.
- •Ability to understand and willingness to sign a written informed consent and to be able to follow the visit schedule.
- •Female patients at child-bearing age must have negative pregnancy test.
- •Patients refuse to have treatment with Chemotherapy or Radiation.
Exclusion Criteria
- •Patients within 2 weeks post-minor surgery, 4 weeks post-major surgery to avoid wound healing complications. Percutaneous biopsies require no waiting time prior to study entry.
- •Patients with a recent history of hemoptysis, ≥ 0.5 teaspoon of red blood.
- •Patients who have received prior systemic treatment for their metastatic cholangiocarcinoma.
- •Presence of clinically relevant ascites or liver failure.
- •Patients with extensive symptomatic fibrosis of the lungs.
- •Patients with a known hypersensitivity to RAD001 (everolimus).
- •Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus, deforolimus).
- •History or clinical evidence of central nervous system (CNS) metastases. Note: Subjects who have previously-treated CNS metastases (surgery±radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
- •Are asymptomatic Have had no evidence of active CNS metastases for ≥ 6 months prior to enrollment and Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC)
- •Clinically significant gastrointestinal abnormalities including, but not limited to:
Arms & Interventions
RAD001
Intervention: Everolimus
Outcomes
Primary Outcomes
progression free survival in cholangiocarcinoma patients whom treated with everolimus
Time Frame: One year
Secondary Outcomes
- overall survival rate(Two years)