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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are effective in treating patients with operable pancreatic cancer.
The best outcome for a patient diagnosed with pancreatic cancer is surgery. However many patients have recurrence of the cancer after successful surgery. The investigators are evaluating chemotherapy before surgery, which is a new approach.
In this study, Abraxane and gemcitabine will be tested as treatment for people with operable pancreatic cancer to see if surgery can be successfully performed and if treatment will reduce cancer cells in the tumor at surgery.
Abraxane is approved by the US FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Gemcitabine is approved by the FDA for first line treatment for patients with locally advanced or metastatic cancer of the pancreas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine & Abraxane Pancreatic Cancer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine and Abraxane | Drug | 3 treatments for gemcitabine and abraxane every 28-days for 3 months, prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade III/IV histological response in tumor specimen rate after induction therapy. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events. | From the initial dose of study drug up to 28 days after last dose of study drug. | |
| Tumor response rate to therapy. | Pre and post therapy radiological assessments of the primary tumor will be compared using RECIST criteria. |
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Inclusion Criteria:
Patient has histologically or cytologically confirmed potentially resectable adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
Definition of potentially operable disease
Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
Patient must have received no prior chemotherapy or radiation for pancreatic cancer and no exposure to gemcitabine and/or Abraxane
Patient has the following blood counts at baseline:
Patient has the following blood chemistry levels at baseline:
Patient has acceptable coagulation status as indicated by a PT within normal limits (±15%) and PTT within normal limits (± 15%).
Patient has an ECOG performance status PS 0-1.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ramesh K. Ramanathan, MD | TGen Drug Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Baseline and 16 weeks |
| Change in CA 19-9 | Baseline CA19-9 and subsequent levels will be compared. | Baseline, Day 1 of each cycle, and end of therapy. |
| Resection rate at surgery | The number of patients who have R0 and R1 surgery will be compiled. | At time of surgery |
| Time to recurrence | Time from first dose of study drug to date of first documented progression or date of death, whichever occurs first, assessed up to 60 months. |
| SPARC protein expression in tumor | At time of surgery |
| Overall Survival | Time from the first dose of study drug until date of death from any cause, up to 60 months. |
| St Mary's / Trinity Health Care |
| Grand Rapids |
| Michigan |
| 49505 |
| United States |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55408 | United States |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 19047 | United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |