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

NCT03778879 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: UGIP18131
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenocarcinoma of the Pancreas; Pancreas Cancer

Keywords

Adenocarcinoma; Pancreas; Radiation Therapy; CCX872-B

Outcome Measures

Primary Outcomes (2)

• Percentage of patients who complete radiation therapy, drug treatment and surgery

  Number of patients who proceed through radiation and drug treatment and undergo surgical resection in a timely manner.

  6 weeks

• Percentage of patients who are ineligible for surgical resection due to toxicity from SBRT + CCX872-B or SBRT alone

  Assessment of whether patients are made ineligible for surgical resection solely due to toxicities from SBRT + CCX872-B or SBRT alone. Measure of Grade 3 toxicity directly attributable to SBRT+ CCX872-B or SBRT alone. Analyze rate of grade 2 or greater acute toxicity caused by SBRT with or without CCX872-B. Determination of intraoperative and postoperative surgical morbidity following neoadjuvant treatment including the amount of fibrosis and total operative time.

  12 weeks

Secondary Outcomes (4)

• Number of participants with no further growth of cancer at original site

  2 years

• Number of subjects with recurrence of cancer in other body sites

  2 years

• Mean time to progression of pancreatic cancer

  4 years

• Mean time to death

  4 years

Study Arms (2)

Group 1:With CCX872-B

EXPERIMENTAL

Concurrent SBRT 25 Gy in 5 fractions over 5-7 days, and 21 days of CCX872-B therapy. CCX872-B 150 mg by mouth twice daily approximately 12 hours apart.

Drug: CCX872-B

Group 2:Without CCX872-B

NO INTERVENTION

SBRT Alone: 25 Gy in 5 fractions over 5-7 days

Interventions

CCX872-B DRUG

CCX872-B concurrent with stereotactic body radiation therapy for pancreatic adenocarcinoma.

Group 1:With CCX872-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
• CT w/ contrast or MRI of the abdomen and pelvis with contrast within 6 weeks prior to registration
• CT chest or PET/CT within 6 weeks prior to registration
• 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
• No evidence of metastatic disease and/or non-regional lymph node metastases
• Adequate cardiopulmonary reserves to tolerate surgery
• ECOG performance status 0-2
• 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
• 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
• Patient must sign study specific informed consent prior to study entry
• Anticipated life expectancy ≥ 12 weeks; -

You may not qualify if:

• Prior surgical resection of any pancreatic malignancy
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
• Any prior systemic or radiation treatment, including investigational treatments, of the patient's pancreatic tumor.
• Prior radiotherapy to the region of pancreatic cancer that would result in overlap of radiation therapy fields
• Severe, active comorbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Clinically significant ECG abnormalities e.g. QTcF \>450msec
• Acute viral, bacterial or fungal infection requiring intravenous antibiotics at the within 4 weeks of registration
• Known active HIV, HBV or HCV infections
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
• Uncontrolled diabetes or hypertension
• Serious psychiatric illness or altered mental status
• Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
• Any evidence of distant metastases (M1)

Sponsors & Collaborators

• Alan Katz: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 19, 2018
• Study Start: August 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)