Clinical Trials
Did you know Clearview Cancer Institute has been involved in Clinical Research for over 18 years? Findings from clinical trial research have led to significant advances in cancer prevention and treatment, and Clearview offers numerous clinical trials whereby patients who volunteer for them receive innovative, state-of-the-art cancer care.
Pancreas Cancer
Abraxane - A Randomized Phase III Study of Weekly ABI-007 (Abraxane) plus Gemcitabine (Gemzar) versus Gemcitabine (Gemzar) Alone in Patients with Metastatic Adenocarcinoma of the Pancreas.
Rationale:
- To evaluate the efficacy of the combination of ABI-007 (Abraxane) and gemcitabine (Gemzar) versus gemcitabine (Gemzar) alone in improving overall survival (OS) in patients with metastatic adenocarcinoma of the pancreas.
- To evaluate objective and functional tumor response and progression-free survival (PFS); to evaluate the safety of this combination; to evaluate changes in serum CA19-9 and plasma SPARC levels.
Eligibility:
(general requirements, not all inclusive)
- Must have histologically confirmed metastatic adenocarcinoma of the pancreas. Islet cell neoplasms are excluded.
- Must have received no previous therapy for the treatment of metastatic disease.
- Must be asymptomatic for jaundice and ascites prior to start.
- Must not use therapeutic Coumadin.
Treatment:
Gemzar and ABI-007 provided by study
Patients will be randomized into one of the following arms:
- Arm A: ABI-007 (Abraxane) 125 mg/m2 IV over 30 minutes, followed by Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes every 3 of 4 week cycles (4th week = rest).
- Arm B: Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes administered weekly for 7 weeks followed by a week of rest (8 week cycle, Cycle 1 only); followed by cycles of weekly administration for 3 weeks followed by one week of rest (4 week cycles).
Contact:
Jane Taylor @ 256-327-5646