A Phase II Study of Locally Advanced Pancreatic Cancer

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary end point is to evaluate the 9-month progression free survival rate and safety profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.

The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: National Cheng-Kung University Hospital; National Taiwan University Hospital
• Treatments: Camptothecin; Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.

2. Patients must have locally advanced pancreatic cancer (LAPC).

3. Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.

• Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with

1. extension to the celiac axis or superior mesenteric artery,

2. occlusion of the superior mesenteric-portal venous confluence

3. aortic, inferior vena cava (IVC) invasion or encasement

4. invasion of SMV below transverse mesocolon or unresectable after surgical exploration.

Those who had superior mesenteric vein impingement, superior mesenteric artery abutment were defined as borderline resectable.

Those who had superior mesenteric vein occlusion, superior mesenteric artery encasement were defined as unresectable.

4. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.

5. Age >20 years and ≦70 years.

6. ECOG performance score of 0 or 1; see Appendix A.

7. Patients must have normal organ and marrow function as defined below:

• absolute neutrophil count >1,500/mL

• platelets >100,000/mL

• total bilirubin <1.5X institutional upper limit of normal

• ALT(SGPT) <5 X institutional upper limit of normal

• creatinine within normal institutional limits or creatinine clearance>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

8. Patients who present with jaundice will be allowed to enroll after control with temporary or permanent internal/external drainage.

9. The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with distant metastases are not eligible.

2. Patients with endocrine or acinar pancreatic carcinoma.

3. Patients may be receiving any steroid, immunologic or other investigational agents within 4 weeks prior to enrollment.

4. Patients who have had prior chemotherapy or radiotherapy are not eligible.

5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.

6. Patients who have above grade II peripheral neuropathy.

7. Patients who had non-curable second primary malignancy within five years, except for non-melanoma skin cancer.

8. 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.

9. Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.

10. Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded from the study because of increased risk of lethal infections and possible pharmacokinetic interactions with study agent administered during the study.

11. Those who have chronic diarrhea.