A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer
Phase 1
Active, not recruiting
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT02481635
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.
- Detailed Description
Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Surgical:
- Medically fit for major pancreatic surgery
- No evidence of metastases
- No prior resection
- Arterial involvement limited to a single major vessel and is resectable
- Tumour-free margins could be achieved
- Acceptable length of vessel
- Mass considered otherwise resectable by current standards
General:
- Less than 70 years old
- Performance status <=2
- Has pancreatic adenocarcinoma
- Adequate bone marrow and organ function
- Therapeutic heparin is allowed
- Taking chronic erythropoietin are permitted
- Not pregnant
- Agree to use contraception
- Able to provide written consent
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Exclusion Criteria
Surgical:
- Aortic involvement
- Involvement of 2 major arterial trunks
- SMV/portal venous occlusion, cannot be reconstructed
- Extensive venous involvement, no arterial involvement
- Disease progression on neo-adjuvant treatme
General:
- Concurrent cancer diagnosis
- Other malignancies unless all therapy completed, no disease for >=3 years
- Prior radiotherapy or chemo within 1 year, to pancreas
- Bone marrow transplant/stem cell rescue
- Major surgery <4 wks prior
- Distant metastases
- Renal dysfunction
- Pulmonary insufficiency
- History of cardiac disease
- Active systemic infection(s) or any other related illnesses
- Known HIV, HBV, HCV
- History of solid organ transplant, cardiovascular disease, inflammatory bowel disease, or underlying neuropathy
- Conditions interfering with patient participation
- Known or suspected allergy to study drugs
- Pregnant or breast-feeding
- Therapeutic coumadin
- More than or equal to Grade 2 pre-exiting peripheral neuropathy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine/Nab-paclitaxel, Radiation and Surgery Gemcitabine Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles. Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles. Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction) Surgery: Tumor resection and arterial resection/reconstruction Gemcitabine/Nab-paclitaxel, Radiation and Surgery Nab-paclitaxel Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles. Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles. Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction) Surgery: Tumor resection and arterial resection/reconstruction Gemcitabine/Nab-paclitaxel, Radiation and Surgery Radiation Therapy Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles. Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles. Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction) Surgery: Tumor resection and arterial resection/reconstruction Gemcitabine/Nab-paclitaxel, Radiation and Surgery Surgical Resection Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles. Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles. Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction) Surgery: Tumor resection and arterial resection/reconstruction
- Primary Outcome Measures
Name Time Method Type and the severity of side effects 5 years
- Secondary Outcome Measures
Name Time Method Average length of hospital stay per patient 5 years Number of surviving patients at 30-days after surgery 30 days after surgery Time to Progression 5 years Number of surviving patients at 1 year after treatment 1 year Number of patients who disease has not progressed 2 years Number of patients that are able to receive surgery after chemoradiation 5 years Number of surviving patients at 90-days after surgery 90 days after surgery Number of patients who need to be re-admitted to the hospital at 90-days after surgery 90 days after surgery
Trial Locations
- Locations (1)
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada