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View Clinical Trial (Medical Research Study)
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A Trial of Patients With Metastatic Adenocarcinoma of the Pancreas - NCT00844649-53226 (Clinical Trial 377455)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy377455.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53226 |
| Conditions: |
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Metastatic Pancreatic Cancer |
| Purpose: |
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Phase III Metastatic Pancreatic Cancer
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| Study summary: |
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This is an open-label, randomized, multi-center Phase III trial to compare ABI-007 in
combination with gemcitabine administered weekly to standard treatment (gemcitabine
monotherapy) with respect to overall survival, objective tumor response rate and PFS in
patients diagnosed with metastatic adenocarcinoma of the pancreas. |
| Criteria: |
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Inclusion Criteria:
A patient will be eligible for inclusion in this study only if all of the following
criteria are met:
1. Patient has histologically or cytologically confirmed and measurable/evaluable
metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are
excluded.
2. Male or non-pregnant and non-lactating female, ≥18 years of age.
- If a female patient is of child-bearing potential, as evidenced by regular
menstrual periods, she must have a negative serum pregnancy tes (ß-hCG)
documented 72 hours prior to the first administration of study drug.
- If sexually active, the patient must agree to use contraception considered
adequate and appropriate by the Investigator.
3. Patient must have received no previous radiotherapy, surgery, chemotherapy or
investigational therapy for the treatment of metastatic disease. Prior treatment
with 5-FU or gemcitabine administered as a radiation sensitizer during and up to 4
weeks after radiation therapy is allowed (if there is lingering toxicity then the
sponsor should be consulted). If a patient received gemcitabine in the adjuvant
setting, tumor recurrence must have occurred at least 6 months after completing the
last dose of gemcitabine.
4. Patient has adequate biological parameters as demonstrated by the following blood
counts as baseline:
- Absolute neutrophil count (ANC ≥1.5 X 10۹/l;
- Platelet count ≥ 100,000/mm3 (100 x 10۹/L);
- Hemoglobin (Hgb)≥ 9 g/dL.
5. Patient has the following blood chemistry levels at baseline:
- AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal range (ULN), unless liver
metastases are clearly present, then ≤ 5 x ULN is allowed
- Total bilirubin ≤ ULN
- Serum creatinine within normal limits or calculated clearance ≥ 60mL/min/1.73 m2
for patients with serum creatinine levels above the institutional normal value.
6. Patient has acceptable coagulation studies as demonstrated by prothrombin time (PT)
and partial thromboplastin time (PTT) within normal limits (± 15%).
7. Patient has no clinically significant abnormalities in urinalysis results.
8. Patient has a Karnofsky performance status (KPS) ≥70.
9. Patient has one or more metastatic tumors measurable by CT scan or MRI, if patient is
allergic to CT contrast media.
10. Patients should be asymptomatic for pain, jaundice and ascites prior to Day One.
11. Patient has been informed about the nature of the study and has agreed to participate
in the study and signed the Informed Consent Form (ICF) prior to participation in any
study-related activities.
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following
criteria apply:
1. Patient has known brain metastases, unless previously treated and well-controlled for
at least 3 months (defined as clinically stable, no edema, no steroids and stable in
2 scans at least 4 weeks apart).
2. Patient uses therapeutic coumadin [ for a history of pulmonary emboli and deep vein
thrombosis(DVT).
3. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
systemic therapy.
4. Patient has know infection with HIV, hepatitis C.
5. Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery
done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks
prior to Day One of treatment in this study.
6. Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy
within 3 weeks prior to study entry weeks (6 weeks for nitrosureas or mitomycin C).
7. Patient has a history of allergy or hypersensitivity to any of the study drugs.
8. Patient has serious medical risk factors involving any of the major organ systems
such that the Investigator considers it unsafe for the patient to receive an
experimental research drug.
9. Patient is unwilling or unable to comply with study procedures.
10. Patient is enrolled in any other clinical protocol or investigational trial |
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| Study is available at: |
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Medical College of Wisconsin
Milwaukee, WI 53226
United States
Primary Contact:
Katie Worzalla
Email: kworzalla@mcw.edu
Phone: 414-805-8972
Secondary Contact:
Amanda Johnson
Email: ajohnson@abraxisbio.com
Phone: 919-433-8449 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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