64Cu-DOTA-ECLIi for Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
64Cu-DOTA-ECLIi - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

CCR2 PET for Pancreatic Cancer Imaging and Prediction of Response to Standard and CCR2-Targeted Therapy

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)

Study Objectives

This trial is evaluating whether 64Cu-DOTA-ECLIi will improve 4 primary outcomes in patients with Pancreatic Adenocarcinoma (Ductal Adenocarcinoma). Measurement will happen over the course of Completion of first scan (day 1).

Month 2
Evaluate whether tumor take of 64Cu-DOTA-ECL1i post therapy correlates with CCR2 expression and is predictive of response to therapy as measured by visual tumor uptake on 64Cu-DOTA-ECL1i images
Month 2
Evaluate if tumor take of 64Cu-DOTA-ECL1i is predictive of response to CCR2-directed therapy measured by comparison of SUVmax at imaging prior to the start of CCR2 directed therapy and SUVmax at imaging performed after 2 cycles of CCR2 directed therapy
Day 1
Cohort 1b only: Evaluate whether tumor uptake of 64Cu-DOTA-ECL1i prior to therapy predicts response to standard of care chemotherapy as measured by tumor SUVmax
Determine whether 64Cu-DOTA-ECL1i detects CCR2 expression in PDAC tumors as measured by direct comparison of visual tumor uptake on 64Cu-DOTA-ECL1i images to CCR2 measurements in surgical specimens

Trial Safety

Safety Progress

1 of 3

Other trials for Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)

Trial Design

3 Treatment Groups

Cohort 2: CCR2-Targeted Therapy
1 of 3
Cohort 1a: Any Treatment Group
1 of 3
Cohort 1b: Standard of Care Treatment Chemotherapy
1 of 3
Experimental Treatment

This trial requires 75 total participants across 3 different treatment groups

This trial involves 3 different treatments. 64Cu-DOTA-ECLIi is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort 2: CCR2-Targeted TherapyLocally advanced or borderline resectable pancreatic cancer Biopsy per therapeutic protocol (if available tissue to be used for CCR2 expression) 64Cu-DOTA-ECL1i-PET/CT imaging pretherapy 2 cycles of CCR2-targeted therapy Biopsy per therapeutic protocol (tissue to be used for CCR2 expression) --Additional 64Cu-DOTA-ECL1i-PET/CT imaging after 2 cycles of therapy
Cohort 1a: Any Treatment GroupEarly-staged localized pancreatic cancer Standard of care diagnostic biopsy 64Cu-DOTA-ECL1i-PET/CT imaging - immediately after the dynamic study Receive treatment with upfront surgery such as whipple procedure
Cohort 1b: Standard of Care Treatment ChemotherapyBorderline resectable, locally advanced/metastatic or recurrent pancreatic cancer Standard of care diagnostic biopsy (if available tissue to be used for CCR2 expression) 64Cu-DOTA-ECL1i-PET/CT imaging pretherapy Treatment with any standard of care (SOC) chemotherapy Additional 64Cu-DOTA-ECL1i-PET/CT imaging for patients with positive scan at baseline/early therapy at the time of standard of care follow-up imaging appointment --Additional 64Cu-DOTA-ECL1i-PET/CT imaging for patients with negative scan at baseline/early therapy at time recurrence is diagnosed by any standard imaging modality
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT
2020
Completed Phase 3
~1060

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and after 2 cycles of ccr2 directed therapy (estimated to be 2 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and after 2 cycles of ccr2 directed therapy (estimated to be 2 months) for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Pancreatic Adenocarcinoma (Ductal Adenocarcinoma). There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
newly diagnosed early-staged localized pancreatic ductal adenocarcinoma (PDAC) scheduled to undergo Whipple procedure (cohort 1a) OR borderline resectable, locally advanced, metastatic, or recurrent PDAC (cohort 1b) scheduled to undergo chemotherapy OR borderline resectable, locally advanced PDAC (cohort 2) who is eligible and / or signed consent to undergo CCR2-targeted therapy example:[(phase 1/2 clinical trial combining an oral CCR2/5i (BMS-813160) with chemotherapy (gemcitabine plus nab-paclitaxel) and anti-PD-1 (nivolumab), PI, Dr. Kian Lim) HRPO #201806007]
at least one measurable [defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI] A cohort 1B subject who has been previously treated for PDAC with a diagnosis of recurrence and a lesion size of 1.5 cm or greater will be allowed to enroll before institution of therapy or within 20 days after starting a 2nd line or later (new therapy) for recurrent disease.
Able to give informed consent
Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-DOTA-ECL1i) is negative

Patient Q&A Section

What are common treatments for pancreatic adenocarcinoma (ductal adenocarcinoma)?

"Pancreatic ductal adenocarcinomas are treated by major surgical techniques such as distal pancreatectomy, local surgery, and neoadjuvant chemotherapy in selected patients. New surgical techniques such as subserosal dissection and robot-assisted hepaticoduodenectomy might be more efficient in selected patients." - Anonymous Online Contributor

Unverified Answer

What causes pancreatic adenocarcinoma (ductal adenocarcinoma)?

"It appears that this condition is not just a single entity, but a group of conditions which are caused, or worsened, by a variety of different factors. For most ductal adenocarcinoma patients, the cancer appears to have formed for a long time. Many patients with ductal adenocarcinoma develop the condition as a result of a previous history of other cancers, including liver and colon, and in less common circumstances there may be a link between genetics, toxins, and other environmental insults." - Anonymous Online Contributor

Unverified Answer

What are the signs of pancreatic adenocarcinoma (ductal adenocarcinoma)?

"A palpable abdominal mass is present in approximately 20% of patients with pancreatic cancer. Other signs include anemia, abdominal pain, jaundice, and weight loss. This article outlines the signs of pancreatic adenocarcinoma." - Anonymous Online Contributor

Unverified Answer

How many people get pancreatic adenocarcinoma (ductal adenocarcinoma) a year in the United States?

"Around 25,000 people get pancreatic adenocarcinoma a year in the United States. This is the third most common cancer (after colorectal cancer and breast cancer) in American men." - Anonymous Online Contributor

Unverified Answer

Can pancreatic adenocarcinoma (ductal adenocarcinoma) be cured?

"Pancreatic ductal adenocarcinoma is commonly associated with a poor prognosis. However, surgery and chemotherapy are highly effective and a cure can be achieved with long-term follow-up." - Anonymous Online Contributor

Unverified Answer

What is pancreatic adenocarcinoma (ductal adenocarcinoma)?

"Pancreatic adenocarcinoma (ductal adenocarcinoma), also known as adenocarcinoma of the pancreas. It is a form of adenocarcinoma of the pancreas whose malignant cells originate from the pancreas. The malignant cells of pancreatic adenocarcinoma are capable of spreading and producing more malignant cells, metastasizing, and eventually forming an aggressive tumor.\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving 64cu-dota-eclii?

"There are more than one million treatments annually for [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) in Ontario. Of these, approximately 45,000 involve chemotherapy and over 5% involve 64Cu-DOTA-eclii. No clinical trial was found concerning 64Cu-DOTA-eclii treatment of patients with colorectal cancer. Until there is a better understanding of colorectal cancer, our present knowledge of therapy for cancer is largely based on research done using other modes of imaging. Clinical trials in this area are needed." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets pancreatic adenocarcinoma (ductal adenocarcinoma)?

"This is the first study to produce a complete analysis of age at the time of diagnosis for pd-pCRM. Results from a recent paper of this study demonstrate that there is no consensus among surgeons or pathologists, whether or not pd-pCRM should be regarded as a "serous" or a non-serous tumor. This fact, and the lack of the consensus as to "serous" versus non-serous pd-pCRM, is probably the most important reason why pd-pCRM behaves differently than previously thought. The data also show that p-PD-pCRM is a disease of the very old." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for pancreatic adenocarcinoma (ductal adenocarcinoma)?

"Because this is a rare disease, the only patients that can benefit from clinical trials should likely be those with a poor prognosis, or those that prefer curative treatment, regardless of trial outcomes." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in 64cu-dota-eclii for therapeutic use?

"The majority of the 64Cu-dota-eclii treatment centers in Germany have shifted from ECLIT alone to BEACT-2, the BEACH-2/EART trial comparing ECLIT with standard chemoimmunotherapy. In many studies, the chemotherapy-related death rate is now markedly reduced in BEACT-2 compared to ECLIT. In the following years, more chemotherapy regimens, in particular the TACE approach, will be investigated further, which might result in more efficient treatment, which can result in much improved survival rates in advanced stages of carcinoma of the pancreas." - Anonymous Online Contributor

Unverified Answer

Has 64cu-dota-eclii proven to be more effective than a placebo?

"Results from a recent clinical trial has demonstrated that 64Cu-dota-eclii, a single radioembolization treatment of pancreatic adenocarcinoma, is an effective treatment. It is associated with low rates of serious toxicities, and allows for the administration of systemic therapy for patients with unresectable pancreatic adenocarcinoma, by a procedure that is easy and safe for patients to undergo. Therefore, 64Cu-dota-eclii should be investigated for further investigations." - Anonymous Online Contributor

Unverified Answer

What is the latest research for pancreatic adenocarcinoma (ductal adenocarcinoma)?

"The treatment of pancreatic cancer in the 21st century is mainly centered on the use of newer technologies and more efficient drugs. The survival rate for pancreatic cancer patients in developed countries has improved considerably recently. However, the median survival period remains in the 1- to 2-year range when compared to the previous decades. There is an urgent need to find a more effective treatment approach for pancreatic cancer. The development of more effective treatments for pancreatic cancer is a goal that deserves our attention and it will benefit all individuals with this rare tumor." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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