Pancreatic CancerPhase 1NCT02237157
A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer
A Phase 1 study testing Gemcitabine, local delivery in people with Pancreatic Cancer, run by RenovoRx at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine, local delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Sep 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
El Camino Hospital, Oncology
Mountain View, California, 94040
Florida Hospital
Tampa, Florida, 33613
About this study
Official title: A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas
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.
Read the detailed description
Patients diagnosed with unresectable pancreatic cancer who may or may not have had prior chemotherapy or radiation therapy may be eligible to enroll in this dose escalation study to determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreatic tumors using the RenovoCath R120 catheter. Patients enrolled may receive up to 8 catheterizations for delivering gemcitabine directly to the pancreatic tumors starting at a reduced dose( 1/4 of standard i.v. gemcitabine dose), then every two doses, increase the dose by 25% if there are no toxicities up to a maximum dose of 1000 mg/m2. There are four cycles, with two doses per cycle. Imaging studies will be conducted as well as assessment for standard, myelosuppresive and gastric toxicities will be assessed. Pain will also be measured throughout the study.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, local delivery
- Keywords
- pancreatic cancer, unresectable, gemcitabine, device, local delivery, chemoembolization
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, local deliveryDrug
Also called Gemzar
Intra-arterial targeted drug delivery
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Local Delivery (Dose 1) | Other | Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose Receives: Drug: Gemcitabine, local delivery |
| Gemcitabine, Local Delivery (Dose 2) | Other | Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose Receives: Drug: Gemcitabine, local delivery |
| Gemcitabine, Local Delivery (Dose 3) | Other | Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose Receives: Drug: Gemcitabine, local delivery |
| Gemcitabine, Local Delivery (Dose 4) | Other | Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose Receives: Drug: Gemcitabine, local delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week post treatment
Secondary outcomes (1)
CA19-9 Tumor Reduction
Measurements of CA19-9 tumor marker are measured pre-treatment and at various time points (starting with one week) post treatment.
Measured: 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenovoRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiali Li, MD, Principal investigator, El Camino Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237157
- Sponsor's protocol ID
- RR1
- Status last verified
- Apr 2021
- First submitted
- 8 Sep 2014
- Last updated
- 7 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39049803
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT02237157
- Acronym / sponsor ID
- RR1
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, unresectable, gemcitabine, device, local delivery, chemoembolization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RenovoRxIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Posted 7 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients diagnosed with unresectable pancreatic cancer who may or may not have had prior chemotherapy or radiation therapy may be eligible to enroll in this dose escalation study to determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreatic tumors using the RenovoCath R120 catheter. Patients enrolled may receive up to 8 catheterizations for delivering gemcitabine directly to the pancreatic tumors starting at a reduced dose( 1/4 of standard i.v. gemcitabine dose), then every two doses, increase the dose by 25% if there are no toxicities up to a maximum dose of 1000 mg/m2. There are four cycles, with two doses per cycle. Imaging studies will be conducted as well as assessment for standard, myelosuppresive and gastric toxicities will be assessed. Pain will also be measured throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Local Delivery (Dose 1) | Other | Drug: Gemcitabine, local deliveryGemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose |
| Gemcitabine, Local Delivery (Dose 2) | Other | Drug: Gemcitabine, local deliveryGemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose |
| Gemcitabine, Local Delivery (Dose 3) | Other | Drug: Gemcitabine, local deliveryGemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose |
| Gemcitabine, Local Delivery (Dose 4) | Other | Drug: Gemcitabine, local deliveryGemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine, local deliveryAlso: GemzarIntra-arterial targeted drug delivery | Drug | Gemcitabine, Local Delivery (Dose 1), Gemcitabine, Local Delivery (Dose 2), Gemcitabine, Local Delivery (Dose 3), Gemcitabine, Local Delivery (Dose 4) |
Primary outcome
Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas
Time frame: 1 week post treatment
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 secondary outcome
CA19-9 Tumor Reduction
Time frame: 1 week after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39049803Hatoum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiali Li, MD principal investigator
El Camino Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine, local delivery in people with Pancreatic Cancer, run by RenovoRx at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas (time frame: 1 week post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.