- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080248
Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer
A Phase II Study of Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To determine the response rate by RECIST criteria.
To determine the progression free survival.
To determine the median survival and overall survival at one year.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Total bilirubin ≤ 1.5 x ULN
- AST and ALT ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 mg/dL; if > 1.5 mg/dL, calculated creatinine clearance must be ≥ 50 mL/min
- Urine protein to creatinine ratio < 1; if ≥ 1, then a 24-hour urine protein must be assessed and must be < 1 g in order for patients to be eligible
- Patient must have the ability to understand and the willingness to sign a written informed consent document.
- Eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods.
Exclusion Criteria
- 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)
- Patient has prolonged QT intervals, taking antiarrhythmics or taking other medications that prolong QT
- Patient has poorly controlled hypertension (defined as systolic blood pressure (SBP) of ≥160 mmHg or diastolic blood pressure (DBP) of ≥ 90 mmHg). Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.
- Patient has a history of cerebrovascular accident, pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months.
- Patient has had major surgery, trauma, non-healing wound, fracture, or ulcer within 28 days prior to first dose of gemcitabine and/or study drug (procedures such as catheter placement not considered to be major) OR minor surgery within 14 days prior to first dose of gemcitabine and/or study drug.
- Patient has significant proteinuria as evidenced by urine protein/creatinine ratio >1
- Patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active second malignancy, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient is pregnant or breastfeeding. Pregnant women are excluded from this study because pre-clinical reproductive toxicity studies with pazopanib demonstrated reduced female fertility and teratogenic effects.
- Patient is known HIV-positive. These patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Patient is a known alcohol, cocaine, or IV drug abuser within 6 months prior to enrollment.
Patient is receiving treatment with any of the following anti-cancer therapies:
- Radiation therapy, surgery, or tumor embolization within 4 weeks prior to the first dose of pazopanib OR
- Chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy within 28 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib.
- Patient is experiencing any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity.
- Inclusion of Women and Minorities
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1 (gemcitabine & pazopanib)
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. |
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate by RECIST Criteria.
Time Frame: Follow-up was approximately 9 weeks
|
|
Follow-up was approximately 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 1 year
|
1 year
|
|
Progression-free Survival (PFS)
Time Frame: Follow-up was approximately 9 weeks
|
|
Follow-up was approximately 9 weeks
|
Median Survival
Time Frame: Length of follow-up was 35 weeks
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Length of follow-up was 35 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- 10-0434 / 201103201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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