A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer

Completed · Phase 1

Conditions studied: Pancreatic Cancer

In brief

A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.

Key facts

Study ID

NCT02237157

Run by

RenovoRx

People needed

20

Starts

2015-03-01

Expected to finish

2016-09-01

Last updated by the study team

2021-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be eligible to participate in the study if all of the following criteria are met:
• Males and female subjects 18 years of age and older.
• Subjects with locally advanced unresectable adenocarcinoma (cytological or histologic proof required) of the pancreas.. Patients with islet cell tumors are not eligible.
• No clinical evidence of distant metastases, excluding single liver metastasis and local lymph node involvement. Patients with more than a single liver metastasis and/or other metastases who have already failed systemic chemotherapy and/or are on a break from systemic chemotherapy who are not surgical candidates can also qualify for this study.
• Karnofsky Performance Status (KPS) >60.
• Adequate renal, and bone marrow function described as:
• Leukocytes ≥ 3,000/uL
• Absolute neutrophil count ≥ 1,500/uL
• Platelets ≥100,000/uL
• Serum creatinine ≥2.0 mg/dL. Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than 40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula.
• Hemoglobin ≥8.5 g/dL (may be receiving supportive therapy)
• PT/PTT (WNL)
• Adequate Hepatic function (endoscopic or percutaneous drainage as needed) described as:
• Total bilirubin ≤3 times UNL (less than or equal to 2 mg/dL)
• AST (SGOT)/ALT (SGPT) ≤ 5 times ULN or ≤5 times ULN in the setting of liver metastases.
• Lipase and Amylase within normal limits.
• Capable of understanding the purpose and risks of the study and willing to provide written informed consent and to comply with the procedures

You may not qualify if…

• Subjects will be excluded from participation in the study if any of the following criteria are met:
• Have a known sensitivity to gemcitabine.
• Identification of metastatic disease, with the exception of single liver metastases or local lymph node involvement. Patients with more than a single liver metastasis and/or other metastases who have already failed systemic chemotherapy and/or are on a break from systemic chemotherapy who are not surgical candidates can also qualify for this study.
• Evidence of coagulopathy.
• Inability or unwillingness to comply with study procedures and/or follow-up procedures.
• Evidence of infection or other coexisting medical condition, which in the opinion of the investigator would preclude administration of gemcitabine.
• Patients with uncontrolled congestive heart failure, unstable angina and myocardial infarction within 3 months.
• Female patient who is pregnant, nursing or planning on becoming pregnant.
• Current enrollment and participation in another clinical study or prior exposure to an investigational agent within 12 weeks or 5 half-lives (whichever is longer) of anticipated dosing on Day 1 of this study.
• Have known brain metastases.
• Have had any major surgery within four weeks of enrollment.
• Have any clinically detectable ascites.
• Have uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Have serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or prostate cancer) not approved by the Medical Monitor (contact MM in event of prior diagnosis with malignancy to discuss enrollment status).
• Have had any chemotherapy or systemic corticosteroids within 2 weeks of study entry.
• Have acquired, hereditary or congenital immunodeficiency's including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia or hepatitis.
• Have a prior history of a documented hemolytic event.
• Is HIV-positive or Hepatitis positive.

Where it is running

• El Camino Hospital, Oncology — Mountain View, California, United States
• Florida Hospital — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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