Combination treatment for pancreatic cancer
Window of Opportunity for Neoadjuvant Stroma Modification in Pancreatic Cancer
This study is testing a combination of three drugs to see if they can improve treatment for patients with pancreatic cancer who have already received therapy before surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fox Chase Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05365893 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a combination of three drugs—paricalcitol, hydroxychloroquine, and losartan—on pancreatic ductal adenocarcinoma (PDAC) and its surrounding stroma. It aims to assess the feasibility and safety of these stroma-modifying agents in patients who have undergone neoadjuvant therapy before surgery. The trial will involve collecting blood and tissue samples to evaluate the biological activity of the treatment. Ultimately, the goal is to establish a new treatment paradigm that could enhance the effectiveness of chemotherapy in treating PDAC.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed, histologically confirmed, resectable non-metastatic pancreatic adenocarcinoma who are scheduled for surgery after neoadjuvant therapy.
Not a fit: Patients with metastatic pancreatic cancer or those who are not candidates for surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with pancreatic cancer by enhancing the effectiveness of chemotherapy.
How similar studies have performed: While this approach is novel, previous studies have explored stroma-modifying therapies in cancer treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for all study participants: * Patients must have new diagnosed histologically or cytologically confirmed pancreatic adenocarcinoma. * Patients must have resectable non-metastatic PDAC and anticipate receiving surgery in a minimum of 4 weeks and a maximum of 12 weeks from completing neoadjuvant chemotherapy and radiation. * Patients are planned for a minimum of 3 months of modified FOLFIRINOX treatment followed by chemo/radiation followed by surgical resection. * Age \> 18 years. * ECOG performance status 0-1 * Patients must have normal organ function as defined below * Total bilirubin within normal institutional limits * AST/ALT (SGOT/SGPT) \< 5 times institutional normal limits * Creatinine within normal institutional limits OR * Creatinine clearance \> 30 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal * Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrhoeic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed. * Ability to understand and willingness to sign a written informed consent and HIPAA consent document Exclusion Criteria for all study participants: * Tumors of acinar or adenocarcinoma histology * Patients may not be receiving any other investigational agents * Patients currently receiving hydroxychloroquine or an angiotensin II receptor blocker * Patients with radiological or cytologically confirmed metastatic or unresectable disease * Pregnant or breast feeding. Refer to section 4.4 for further detail. Inclusion criteria for participation in experimental PHL therapy (Arm A): * Patients must have resectable non-metastatic PDAC and anticipate receiving surgery in a minimum of 4 weeks and a maximum of 12 weeks from completing neoadjuvant chemotherapy and chemoradiation. * Patients completed a minimum of 3 months of modified FOLFIRINOX treatment followed by chemoradiation prior to study enrollment and plans for surgical resection. * Ability to understand and willingness to sign a written informed consent and HIPAA consent document Exclusion Criteria for participation in Experimental PHL Therapy (Arm A): * Patients who have residual grade 3 or higher adverse events from prior chemotherapy or chemoradiotherapy for pancreatic cancer * Concomitant use of an ACE inhibitor or ARB, vitamin D, or hydroxychloroquine. Patient may elect to stop Vitamin D supplement and will be allowed to enroll on the study. * Patients cannot have a history of retinopathy, macular degeneration or other severe ocular issues, baseline hypotension (systolic blood pressure lower than 100 mmHg on two separate readings obtained on two separate days), or history of hypercalcemia requiring treatment * Patients with known disorders precluding use of any of the study drugs including a history of angioedema, hypotension, or renal disease (CrCl \< 30mL/min). * History of allergic reactions attributed to compound of similar chemical or biologic composition to the agent(s) used in this study * Patients receiving any medications or substances that significantly interact with PHL are ineligible (specified in section 5.2). * A marked baseline prolongation of QT/QTc interval * A history of additional risk factors for Torsades de Pointes (e.g., heart failure, family history of Long QT Syndrome) * Atrio-ventricular blockade of 2nd or 3rd degree * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breast feeding.
Where this trial is running
Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Sanjay Reddy, MD, FACS — Fox Chase Cancer Center
- Study coordinator: Sanjay Reddy, MD, FACS
- Email: Sanjay.Reddy@fccc.edu
- Phone: (888) 369-2427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.