Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer

NCT01080248 | Terminated Phase 2 Results

• 1 other identifier: 10-0434 / 201103201
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the response rate and survival of gemcitabine and pazopanib in patients with metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

Pancreas

Outcome Measures

Primary Outcomes (1)

• Response Rate by RECIST Criteria.

  * Response rate = complete response + partial response per RECIST * Complete response - disappearance of all target and non-target lesions. * Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter

  Follow-up was approximately 9 weeks

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Follow-up was approximately 9 weeks

• Median Survival

  Length of follow-up was 35 weeks

• Overall Survival

  1 year

Study Arms (1)

Arm 1 (gemcitabine & pazopanib)

EXPERIMENTAL

Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle. Pazopanib 800 mg PO daily of each 28 day cycle.

Drug: Gemcitabine; Drug: Pazopanib

Interventions

Gemcitabine DRUG

Also known as: Gemzar

Arm 1 (gemcitabine & pazopanib)

Pazopanib DRUG

Also known as: Votrient

Arm 1 (gemcitabine & pazopanib)

Eligibility Criteria

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

You may qualify if:

• Patient must have a histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
• Patient must have metastatic disease that is not amenable to surgical resection.
• Patient must have measurable disease (by RECIST criteria), defined as at least one lesion that can be accurately measured in at least one dimension.
• Patient may have previously untreated disease or may have been previously treated if they meet the following criteria:
• received adjuvant gemcitabine therapy \>6 months prior to enrollment with progression off therapy
• received prior radiation therapy \> 4 weeks prior to study enrollment and have measurable tumor mass outside the radiation field
• received prior radiation therapy \> 4 weeks prior to study enrollment, have a measurable tumor mass outside the radiation field, and received 5-FU as a radiation sensitizer \>4 weeks prior to study enrollment
• Patient must be \>=18 years old. Note: pazopanib is contraindicated in the pediatric population due to the potential effect on the epiphyseal growth plates.
• Patient must have an ECOG performance status of 0-1
• Patient must have normal organ and marrow function within 14 days of study initiation as defined below:
• ANC ≥ 1.5 x 109/L
• Hemoglobin ≥ 9 g/dL; patients may not have had a transfusion within 7 days of screening assessment
• Platelets ≥ 100 x 109/L
• PT or INR ≤ 1.2 x upper limit of normal (ULN)
• PTT ≤ 1.2 x ULN

You may not qualify if:

• Patient has been treated with an agent that antagonizes the VEGF receptor.
• Patient has received any other investigational agents \< 28 days prior to enrollment.
• Patient has known brain metastases; these patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. In addition, patients with brain metastases may be at a higher theoretical risk for cerebral hemorrhage while taking pazopanib.
• Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib, gemcitabine, or other agents used in the study.
• Patient has an increased risk of hemorrhage such as having received thrombolytic agents within the past month, being on an unstable dose of anticoagulation, or having a known bleeding diathesis.
• Patient has a clinically significant gastrointestinal abnormality that may increase the risk for GI bleeding such as:
• Active inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) or other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess ≤ 28 days prior to beginning study treatment
• Patient has a history of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting
• Myocardial infarction
• Unstable angina
• Coronary artery by-pass graft surgery
• Symptomatic peripheral vascular disease
• Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; pazopanib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Joel Picus, M.D.
• Organization: Washington University School of Medicine

jpicus@dom.wustl.edu

314-362-5740

Study Officials

• Joel Picus, M.D.

  Washington University School of Medicine

  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

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: October 1, 2011
• Last Updated: June 9, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-05

Locations

US (1)