Combination treatment for metastatic pancreatic cancer
A Phase I/Ib Pilot Trial, Single Arm, Open Label, of Protein-Bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) in Patient With Metastatic Pancreatic Adenocarcinoma
This study is testing a new combination treatment for people with advanced pancreatic cancer to see if it can help them feel better after their initial therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04605913 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of a combination therapy using Protein-bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) alongside Tumor Treatment Fields (TTF) in patients with metastatic pancreatic cancer. It is a Phase I/Ib, single-center, non-randomized, open-label study aimed at assessing the tolerability and potential benefits of this innovative treatment approach. The study hypothesizes that the combination of GCN and TTF could transform the standard of care for patients with stage IV pancreatic cancer, especially in terms of maintenance therapy after initial treatment cycles. If successful, this pilot study may lead to larger confirmatory trials.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis and no prior lines of therapy for stage IV metastatic disease.
Not a fit: Patients with squamous, small cell carcinoma, or acinar cell carcinoma are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with metastatic pancreatic cancer.
How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
1. Subjects with additional sites of metastasis, except known brain metastasis, are eligible.
2. Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled.
3. Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (MRI/CT scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult.
2. Patients with no prior lines of therapy for the treatment of stage IV metastatic disease.
1. Patients could have had prior neoadjuvant or adjuvant chemotherapy or chemo-radiotherapy.
i. Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress greater than 6 months after completion of the therapy; ii. Patients who progress while on adjuvant FOLFIRINOX can enroll immediately.
3. Male and female patients at least 18 years of age
4. Laboratory data as specified below:
Hematology:
\- ANC greater than 1500 cells/mm3,
\- platelet count greater than 100,000 cells/mm3, and
\- Hemoglobin greater than 8 g/dL.
* Hepatic
* Total bilirubin less than 1.5 X ULN;
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 X ULN.
For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 6.0 X ULN and total bilirubin less than 3 x ULN.
* Renal:
* serum creatinine WNL or creatinine clearance greater than 50 mL/min.
5. QT intervals: QTc less than or equal to 470 msec for men and less than or equal to 490 msec for women. (As measured by Hodges' Equation: QTc = QT + 1.75(rate-60) where QTc = corrected QT interval and rate = ventricular rate/min).
6. Estimated life expectancy of at least 3 months
7. ECOG Performance Status 0-1.
8. Ability to operate the Novo TTF-100L (P) system.
9. Patients must have measurable disease on scans per RECIST 1.1.
10. Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment.
Exclusion Criteria:
1\. Previous front-line therapy for metastatic disease.
1. Patients with known brain metastasis.
2. Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker.
3. Patient with cardiac or abdominal pacemakers or stimulators.
4. Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction.
5. Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible.
6. Concomitant use of drugs that have black box warning of Torsades de Pointes will also be prohibited if cannot be replaced by another drug.
7. Known sensitivity to conductive hydrogels.
10\. Patients who are pregnant or breastfeeding.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Hani M. Babiker, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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.