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Completed

NCT Number: NCT01903083

Chemoimmunotherapy and Radiation in Pancreatic Cancer

The goal of this study is to evaluate the safety of combination treatment that includes chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.

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Key information

Conditions

Locally Advanced Malignant Neoplasm Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Portland Providence Medical Center

Portland, Oregon, 97213, United States

About this study

This study is for borderline resectable and advanced pancreatic cancer patients. Patients will receive chemotherapy with gemcitabine and immunotherapy with daily tadalafil during the first 21 days of treatment. On study day 22, patients will receive the first of three planned doses of radiation therapy and continue daily tadalafil. Patients are then evaluated to determine if they are candidates for pancreaticoduodenectomy. Patients who are not candidates will continue daily tadalafil and receive gemcitabine chemotherapy. Patients who have surgery will resume daily tadalafil and gemcitabine chemotherapy following recovery from surgery. Patients will receive up to four cycles of gemcitabine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pancreatic adenocarcinoma
  • Locally advanced unresectable disease, or borderline resectable disease
  • ECOG (Eastern Cooperative Oncology Group)Performance Status 0 or 1
  • Ability to provide consent and comply with study protocol
  • Women of child-bearing potential must have a negative pregnancy test and avoid pregnancy during the study

Exclusion criteria

  • Age < 18
  • History of other malignancy in previous 2 years except carcinoma in situ of the cervix or bladder, or non-melanoma skin cancer
  • Previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation to the target field
  • Clinically active autoimmune disease or active infection
  • History of heart attack within 90 days or stroke within 6 months, hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (NYHA >= Class 2 in last 6 months), unstable angina, or angina during sexual activity
  • Use of nitrates or nitroglycerin
  • History of hereditary degenerative retinal disorders including retinitis pigmentosa
  • Chronic systemic corticosteroid use at supra-physiologic doses
  • Use of recreational drugs called 'poppers' like amyl nitrite and butyl nitrite
  • Blood test results (neutrophils < 1000 /uL (microliter); hemoglobin < 9 gm /dL; platelet count < 1000 cells / uL; significant coagulopathy; significant liver or renal dysfunction

Treatment and study plan

Tadalafil

Drug

One 2.5 mg tablet is self-administered orally by the study participant on a once daily basis.

Other names: Cialis

Gemcitabine

Drug

Three doses of gemcitabine (1000 mg / m^2)are given over a 21-day cycle. Patients may receive up to 4 cycles.

Other names: Gemzar

Radiation

Radiation

Patients will receive 3 doses of radiation (8-10 Gy per fraction).

Pancreaticoduodenectomy

Procedure

Surgical resection.

Primary outcomes

  1. Safety

    Time frame: 135 Days

    Patients will return be seen in the clinic 8 times over the first 50 days for an evaluation of adverse events and toxicities before being evaluated for surgery. Patients who are not candidates for surgery will be seen in clinic 10 more times over the next 85 days for safety evaluations, and patients who have surgery will be seen 10 times over the 85 days following recovery from surgery for safety evaluations.

Secondary outcomes

  1. Immune Infiltration in pancreaticoduodenectomy tissue

    Time frame: 50 Days

    For surgery patients, formalin fixed and paraffin-embedded tumor tissue obtained during surgery will be sectioned and immunohistology performed to determine the tumor inflammatory micro-environment and the degree of macrophage and T cell inflammation.

  2. Quantification of T cells in peripheral blood pre- and post-treatment

    Time frame: 135 Days

    Patients will provide a pre-treatment blood sample and 4 blood samples over 135 days to evaluate the influence of the study treatment on immune parameters. For patients who have surgery, the time period will be longer depending on their recovery time. Post-treatment long term follow up will occur every 12 weeks (+/- 2 weeks) beyond post-recovery date (PRD) 85 for 6 visits. Blood will be collected for immune monitoring at each visit.

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Phase I Trial of Chemoimmunotherapy and Hypofractionated Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma.

Acronym: CRIT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2013
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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