ClinicalTrials.Veeva

Menu

A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine
Procedure: Surgical Resection
Drug: Nab-paclitaxel
Radiation: Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02481635
ARCAP-GA

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Experimental group
Description:
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
Treatment:
Radiation: Radiation Therapy
Drug: Nab-paclitaxel
Procedure: Surgical Resection
Drug: Gemcitabine

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems