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Clinical Trial 19801

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT03340974

Phase: Phase I/II
Prinicipal Investigator:

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Overview

Study Title

An Adaptive Phase I/II Dose Escalation Trial of Stereotactic Body Radiation Therapy in Combination with Radiomodulating Agent Gc4419 in Locally Advanced Pancreatic Adenocarcinoma

Summary

The goal of this clinical research study is to find the recommended dose of radiation that can be given with or without GC4419 to patients with advanced pancreatic adenocarcinoma. Researchers also want to learn if GC4419 can help to prevent side effects commonly seen in radiation therapy that stop patients from being able to receive increasing radiation doses.

Objective

Primary: To determine the Maximum Tolerated Dose (MTD) of Stereotactic Body Radiation Therapy(SBRT) when given in combination with placebo or GC4419 Secondary: To evaluate Progression-Free Survival (PFS) at MTD for patients treated with SBRT given in combination with placebo or GC4419 To evaluate Overall Response Rate (ORR) including stable disease, partial/complete response at 90 days for patients treated with SBRT given in combination with placebo or GC4419 To evaluate long-term (12 month) toxicity of SBRT in combination with placebo or GC4419 To evaluate tumor resectability after SBRT in combination with placebo or GC4419 To evaluate the R0 Resection Rate and Pathologic Complete Response Rate (pCR) for patients who eventually undergo surgical resection To compare acute toxicity rate at 90 days for patients treated at the SBRT MTD in combination with placebo or GC4419 To compare efficacy rates at 90 days for patients treated at the SBRT MTD with placebo or GC4419

Treatments

Therapies

Medications

GC4419 (); Placebo ()

Inclusion Criteria

Inclusion Criteria

  • Cytologic or biopsy confirmed adenocarcinoma of the pancreatic head, body or tail
  • Disease that is appropriate for SBRT as outlined in protocol.
  • Pancreatic tumor size and limited bowel moement by tumor must be judged acceptable for SBRT at the discretion of the treating investigator.
  • No evidence of distant metastasis either prior to or after induction chemotherapy.
  • Completion of medically indicated first-line chemotherapy, as determined by the treating investigator
  • Patient must have metal stent in place if duodenal stent is required. If patient has plastic stent, this must be replaced prior to radiation.
  • Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to >Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (0, 1 or 2)
  • Adequate hematologic function as indicated by laboratory values defined in protocol.
  • Adequate renal and liver function as indicated by laboratory values defined in protocol.
  • Properly obtained written informed consent in the patient's primary language (English or Spanish). If patient is not sufficiently fluent in either English or Spanish to understand consent, they will not be eligible for the study.

  • Exclusion Criteria

  • Prior radiation therapy to the abdomen that would overlap with treatment field
  • Prior surgical resection of pancreatic tumor
  • Receiving any approved or investigational anti-cancer agent other than those provided for in this study
  • Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
  • Visible invasion of tumor into the lumen of the bowel or stomach on endoscopy (Note: Radiological infiltration into bowel is allowed unless deemed clinically unsafe).
  • Residual or ongoing ≥ Grade 3 toxicity from chemotherapy
  • Contraindication to IV contrast
  • Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study entry Note: Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment
  • Second primary malignancy within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator
  • Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
  • Female patients who are pregnant or breastfeeding
  • Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for 30 days after the last dose of GC4419. This includes any woman who has experienced menarche but has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential.
  • Male subjects who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 90 days after the last dose of GC4419 are excluded.
  • Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
  • Medical history that includes any condition, or requires the use of concomitant medications which, in the investigator's judgment, are associated with or create a risk of increased carotid sinus sensitivity, symptomatic bradycardia, or syncopal episodes.

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