TerminatedPhase 2

Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy

Stopped: Funding not available

United States7 participantsStarted 2010-09

Plain-language summary

Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that lead to inhibition of tumor angiogenesis (a fundamental step in the transition of tumors from a dormant state to a malignant one). Bortezomib triggers cell death in pancreatic cancer cells but the mechanism is not well defined but has been determined to be cytostatic. Combining these two drugs may work together in the treatment of pancreatic cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological diagnosis of locally advanced or metastatic pancreatic cancer (except neuroendocrine tumors, but including ampullary cancer) with progression after standard first line therapy that included gemcitabine (single agent or combination) * Measurable disease on computated tomography (CT) scan per Response Evaluation Criteria in Solid Tumors (RECIST) criteria * At least 28 days from previous systemic therapy, including investigational agents and 1st dose of study treatment and recovered from any acute toxic effects of that treatment before study enrollment. * Has Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 - Ability to provide written consent * Must meet hematology and biochemistry laboratory criteria within 14 days of study enrollment: * Neutrophil count \>1500/mm\^3 * Platelet count \>100,000/mm\^L * Hemoglobin \> or = 9 g/dL * Aspartate aminotransferase (AST/SGOT) or Alanine transaminase (ALT/SGPT) \< or = 2.5 times upper limit of normal (ULN)or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement * Serum bilirubin \< or = 1.5 x ULN * Serum creatinine \< or = 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min * Total serum calcium (corrected for serum albumin) or ionized calcium ≥ lower limit of normal (LLN) * Serum phosphorus \> or = LLN * Serum potassium \> or = LLN * Serum sodium ≥ LLN * Serum magnesium ≥ LLN * Serum albumin ≥ LLN or 3g/dl * Patients with any elevated A…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-Free Survival

Timeframe: Up to 1 Year

Trial details

NCT IDNCT01056601

SponsorMasonic Cancer Center, University of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-02

Results submitted2011-07-28

View on ClinicalTrials.gov More Pancreatic Cancer trials