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

NCT02237157 | Completed Phase 1 Results DMC

• 1 other identifier: RR1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; unresectable; gemcitabine; device; local delivery; chemoembolization

Outcome Measures

Primary Outcomes (1)

• Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas

  Maximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter. One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding.

  1 week post treatment

Secondary Outcomes (1)

• CA19-9 Tumor Reduction

  1 week after treatment

Study Arms (4)

Gemcitabine, Local Delivery (Dose 1)

OTHER

Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose

Drug: Gemcitabine, local delivery

Gemcitabine, Local Delivery (Dose 2)

OTHER

Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose

Drug: Gemcitabine, local delivery

Gemcitabine, Local Delivery (Dose 3)

OTHER

Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose

Drug: Gemcitabine, local delivery

Gemcitabine, Local Delivery (Dose 4)

OTHER

Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose

Drug: Gemcitabine, local delivery

Interventions

Gemcitabine, local delivery DRUG

Intra-arterial targeted drug delivery

Also known as: Gemzar

Gemcitabine, Local Delivery (Dose 1); Gemcitabine, Local Delivery (Dose 2); Gemcitabine, Local Delivery (Dose 3); Gemcitabine, Local Delivery (Dose 4)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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).

Sponsors & Collaborators

• RenovoRx: lead

Study Sites (2)

El Camino Hospital, Oncology

Mountain View, California, 94040, United States

Location

Florida Hospital

Tampa, Florida, 33613, United States

Location

Related Publications (1)

• Hatoum H, Rosemurgy A 2nd, Bastidas JA, Zervos E, Muscarella P 2nd, Edil BH, Cynamon J, Johnson DT, Thomas C, Swinson BM, Nordgren A, Vitulli P, Nutting C, Gipson M, Tsobanoudis A, Agah R. Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2. Oncologist. 2024 Aug 5;29(8):690-698. doi: 10.1093/oncolo/oyae178.

  PMID: 39049803 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Charles Li
• Organization: RenovoRx

charles@renovorx.com

(650) 284-4433

Study Officials

• Jiali Li, MD

  El Camino Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects receive a gradual increase of drug dose, until the full systemic dose is administered. Cycle 1: 250mg/m2. Cycle 2: 500mg/m2. Cycle 3: 750mg/m2. Cycle 4: 1000mg/m2.

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 11, 2014
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 7, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)