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Clinical Trial 19801

Cancer Type: Gastrointestinal Tumor
Interventions:GC4419; Placebo

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Sarah Hoffe

Call 813-745-6100
or 1-800-679-0775
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

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

Inclusion Criteria

  • Cytologic or biopsy confirmed adenocarcinoma of the pancreatic head, body or tail
  • Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at MDACC, including triphasic CT demonstrating tumor abutment of the superior mesenteric artery (SMA) or celiac axis, superior mesenteric vein (SMV) or portal vein (PV) involvement which is not resectable without vascular reconstruction.
  • Pancreatic tumor size ≤ 5cm
  • No evidence of distant metastasis either prior to or after induction chemotherapy.
  • Completion of at least 3 months, but no more than 7 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably with a washout period no longer than 8 weeks.
  • 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
  • Direct invasion of the duodenum by the primary tumor
  • 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.