Pre-operative Stereotactic Body Radiation Therapy for Pancreatic Adenocarcinoma With or Without CCX872-B

• Status: Withdrawn
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Standard treatment for newly diagnosed operable pancreatic cancer usually involves undergoing surgery first and then receiving chemotherapy with or without radiation therapy. However, the pancreatic cancer often comes back after this treatment. Therefore, the investigators are studying whether giving treatment prior to surgery can help decrease the risk the cancer returns.

Stereotactic Body Radiation Therapy (SBRT) is a highly focused type of radiation therapy commonly used in the treatment of pancreatic cancer. This treatment has been shown to be safe and effective for the preoperative treatment of pancreatic cancer. The purpose of this study is to determine if combining an experimental drug, CCX872-B, with SBRT continues to be safe and whether the combination treatment may be more effective at boosting the participant's immune system's ability to kill the pancreatic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alan Katz

Criteria

Inclusion Criteria:

1. Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas

2. CT w/ contrast or MRI of the abdomen and pelvis with contrast within 6 weeks prior to registration

3. CT chest or PET/CT within 6 weeks prior to registration

4. Clinically determined to be resectable based on NCCN Criteria 3.2017: No arterial tumor contact (celiac axis, superior mesenteric artery or common hepatic artery) and no tumor contact with the superior mesenteric vein or portal vein, or < 180 degrees contact without vein contour irregularity

5. No evidence of metastatic disease and/or non-regional lymph node metastases

6. Adequate cardiopulmonary reserves to tolerate surgery

7. ECOG performance status 0-2

8. Adequate bone marrow function defined as follows: White blood cell> 3000cells/mm^3, Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, Platelets ≥ 100,000 cells/mm3, Hemoglobin ≥ 9.0 g/dl

9. Male or female subjects, aged at least 18 years; Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year

10. Patient must sign study specific informed consent prior to study entry

11. Anticipated life expectancy ≥ 12 weeks; -

Exclusion Criteria:

1. Prior surgical resection of any pancreatic malignancy

2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years

3. Any prior systemic or radiation treatment, including investigational treatments, of the patient's pancreatic tumor.

4. Prior radiotherapy to the region of pancreatic cancer that would result in overlap of radiation therapy fields

5. Severe, active comorbidity, defined as follows:

1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

2. Transmural myocardial infarction within the last 6 months

3. Clinically significant ECG abnormalities e.g. QTcF >450msec

4. Acute viral, bacterial or fungal infection requiring intravenous antibiotics at the within 4 weeks of registration

5. Known active HIV, HBV or HCV infections

6. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.

7. Uncontrolled diabetes or hypertension

8. Serious psychiatric illness or altered mental status

6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure

7. Any evidence of distant metastases (M1)

8. (ONLY applies for Group 1 patients taking CCX872-B )Taking agents known to be strong inhibitors or inducers of CYP3A4 or UGT1A1 within 2 weeks prior to Day 1 dosing; these include atazanavir, boceprevir, clarithromycin, conivaptan, gemfibrozil, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, rifampin, and carbamazepine; use of these drugs must be avoided during the study and until 2 weeks after stopping CCX872-B treatment -