UAB 0641
Title: UAB 0641 - A Phase I Trial of Gemcitabine (GemzarTM) Plus ABI-007 (AbraxaneTM) in Patients with Advanced Metastatic Pancreatic
Sponsor: Abraxis BioScience, Inc.
Investigator: Tina E. Wood, M.D.
OBJECTIVES
1. To determine the MTD and DLT of gemcitabine plus ABI-007 in patients with advanced metastatic pancreatic cancer.
2. To evaluate the safety and tolerability of this combination in the patient population.
3. To report any objective antitumor responses and disease stabilizations lasting at least 4 cycles.
STUDY DRUG AND DOSAGE
Patients will be treated on an outpatient basis with gemcitabine plus ABI-007.
Cohorts of 3 patients each will receive gemcitabine 800mg/m2 as a 30 minute infusion plus ABI-007 125mg as a 30 minute infusion on Days 1, 8, and 15 .
Supportive care per the institution's normal standard of care can be provided at the investigator's discretion.
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 metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
2. Male or non-pregnant and non-lactating female, and ³ 18 years of age.
a. If a female patient is of childbearing potential, she must have a negative serum pregnancy test (b-hCG) documented within 72 hours of the first administration of the study drug.
b. If sexually active, the patient must agree to use contraception considered adequate and appropriate by the investigator.
3. Patient must have received no prior 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 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 the following blood counts at baseline:
a. ANC ³ 1.5 x 109/L
b. Platelets ³ 100 x 109/L
c. Hgb ³ 9g/dL
5. Patient has the following blood chemistry levels at baseline:
a. AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal range (ULN), unless liver metastases are present, then ≤ 5 x ULN is allowed.
b. Bilirubin ≤ ULN
c. Serum creatinine within normal limits or calculated clearance ³ 60mL/min/1.73m2 for patients with serum creatinine levels above the institutional normal value.
6. Patient has no clinically significant abnormalities in urinalysis results.
7. Patient has acceptable coagulation status as indicated by a PT within normal limits (±15%) and PTT within normal limits (±15%).
8. Patient has a Karnofsky performance status (KPS) ³ 70 (ECOG PS 0-1).
9. Patient has one or more metastatic tumors measurable by CT scan.
10. Patient has been informed about the nature of the study and has agreed to participate in the study and signed the Informed Consent Form 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 two scans at lease 4 weeks apart).
2. Patient uses therapeutic coumadin for a history of pulmonary emboli and DVT.
3. Patient has active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy.
4. Patient has known infection with HIV, Hepatitis B, or 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 1 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 nitrosoureas or mitomycin C).
7. Patient has a history of allergy or hypersensitivity to the study drug.
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 enrolled in any other clinical protocol or investigational trial.
ADDITIONAL INFORMATION
Contact: Robyn Wilson, RN
Telephone: 205-975-6347
Email: robyn.wilson@ccc.uab.edu
