Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer

NCT00557492 | Completed Phase 2 Results DMC

• 1 other identifier: 06-035
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine the efficacy of bevacizumab and gemcitabine in combination with radiation therapy in the preoperative treatment of potentially-resectable subjects with pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

pancreas; pancreatic; cancer; resectable

Outcome Measures

Primary Outcomes (2)

• Rate of Margin Negative Surgical Resection (R0 Resection Rate)

  Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.

  Up to 48 months

• Rate of Pathologic Complete Response (pCR)

  Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.

  Up to 48 months

Secondary Outcomes (5)

• Overall Survival (OS)

  Up to 48 months

• Progression-free Survival (PFS)

  Up to 48 months

• Rate of Surgical Resection

  Up to 48 months

• Radiographic Tumor Response

  Up to 48 months

• Ca 19-9 Level (in Serum) - Biomarker Response

  Baseline and up to 48 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Intervention: Drug: Avastin (bevacizumab) 10 mg/kg, days 1, 15, 29 and 43 Intervention: Drug: Gemzar (Gemcitabine) On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min). Intervention:Radiation: external beam radiotherapy 3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy

Drug: Avastin (bevacizumab); Drug: Gemzar (Gemcitabine); Radiation: external beam radiotherapy

Interventions

Avastin (bevacizumab) DRUG

10 mg/kg, days 1, 15, 29 and 43

Single Arm

Gemzar (Gemcitabine) DRUG

On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).

Single Arm

external beam radiotherapy RADIATION

3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic proof of pancreatic adenocarcinoma.
• Subjects with biopsy-proven adenocarcinoma of the pancreas which is potentially resectable by preoperative imaging. Subjects will be considered potentially resectable using criteria defined by Pisters (Pisters et al., 2001):
• if imaging detects no evidence of extrapancreatic disease;
• no evidence of tumor extension to the superior mesenteric artery (SMA) or celiac axis (intact fat plane between the tumor and the adjacent visceral artery),
• patent superior mesenteric-portal vein confluence
• no encasement of portal or superior mesenteric vein.
• Karnofsky performance status ≥ 80.
• No active second malignancy except for basal cell carcinoma of the skin
• Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced by:
• Serum creatinine level ≤1.6 mg/dl ( Calculated Creat clearance \>50)
• Serum total bilirubin level ≤1.5 X ULN
• Urine protein excretion ≤ 1+ by urine dipstick
• White blood cell count ≥ 3.5x109/ml per ml and platelet count ≥ 100x109 per ml
• Age \>18 years.
• Children are excluded because of toxic effects of bevacizumab and gemcitabine on growth and development during preclinical studies.

You may not qualify if:

• Subjects who have received chemotherapy within 12 months prior to study entry.
• Prior use of radiotherapy or investigational agents for pancreatic cancer.
• Subjects who have undergone laparotomy for pancreas cancer within 6 weeks
• Any evidence of metastasis to distant organs (liver, lung, peritoneum).
• Symptomatic or endoscopic evidence of gastric outlet obstruction
• Endoscopic findings suggesting tumor erosion into the gastrointestinal mucosa.
• Concurrent malignancies with evidence of active or measurable disease except basal cell carcinoma of the skin.
• Inability to adhere to study and/or follow-up procedures
• History of allergic reactions or hypersensitivity to the study drugs (bevacizumab, gemcitabine, and proton pump inhibitors).
• Other concurrent experimental therapy.
• Because subjects with immune deficiency are at increased risk for lethal infections when treated with marrow-suppressive therapy, HIV-positive subjects receiving combination anti-retroviral therapy are excluded from the study.
• Subjects who have had recent surgery (prior 6 weeks)
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
• Subjects with the following co-morbid medical conditions:
• History of myocardial infarction or unstable angina within 12 months prior to study enrollment.

Sponsors & Collaborators

• Amer Zureikat: lead

Study Sites (1)

University of Pittsburgh Medical Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Bevacizumab; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Herbert Zeh, MD
• Organization: UPMC CancerCenter

zehxhx@upmc.edu

4126922852

Study Officials

• Herbert J. Zeh, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: December 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2016
• Last Updated: September 25, 2018
• Results First Posted: December 12, 2016

Record last verified: 2018-08

Locations

US (1)