Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
Verified May 2013 by Western Regional Medical Center
Information provided by (Responsible Party):
Madappa Kundranda, MD, Western Regional Medical Center
First received: February 15, 2013
Last updated: May 9, 2013
Last verified: May 2013
To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.
Pancreatic Carcinoma Non-resectable
Stage IV Pancreatic Cancer
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer
Primary Outcome Measures:
Secondary Outcome Measures:
- Progression free survival time [ Time Frame: One year ] [ Designated as safety issue: No ]
Determine progression free survival time with this regimen
- Response rate [ Time Frame: One year ] [ Designated as safety issue: No ]
Determine response rate with this regimen
- Duration of response with this regimen [ Time Frame: One year ] [ Designated as safety issue: No ]
Determine duration of response with this regimen
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2014 (Final data collection date for primary outcome measure)
Experimental: Gemcitabine and nab-Paclitaxel
Gemcitabine (1,000/m2)administered intravenously on days 1 and 15, every 28 days
nab-Paclitaxel (125mg/m2)administered intravenously on days 1 and 15, every 28 days
Patients will receive Gemcitabine (1,000mg/m2) IV over 30 minutes after nab-paclitaxel infusion
Other Name: Gemzar
Patients will receive nab-Paclitaxel (125mg/m2) IV over 30 minutes before Gemcitabine infusion
Other Name: Abraxane
This study will help determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly, opposed to a weekly dosing schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
- Patient has one or more radiographically measurable tumor.
- Patients may have received prior therapy with gemcitabine alone or with fluoropyrimidines, erlotinib or radiation therapy (RT) in the past.
- Age ≥ 18 years.
- Patient or legal representative must have read, understood and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.
- ECOG performance status 0 - 2 and an expected survival of at least 3 months.
Acceptable hematological parameters within 2 weeks of commencing study therapy as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin (Hgb) ≥ 9g/dl
Patients with adequate organ function as measured by:
A. Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Hepatic: Bilirubin < 2.0 mg/ and ALT and AST < 1.5x the upper limit of normal.
B. Renal: Creatinine < 1.5 mg/dl and no other chronic kidney disease.
Women must meet one of the following criteria:
- Post-menopausal for at least one year
- Surgically incapable of child-bearing
- Utilizing a reliable form of contraception for the duration of study participation.
Women of child-bearing potential must have a negative serum β-HCG within 7 days of study drug administration.
- Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant or the metastatic setting.
- 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).
- Other significant active or chronic infection.
- History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
- Pregnant or nursing females.
- Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
- Major surgery, other than diagnostic surgery within 4 weeks of study entry. -
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851174
|Western Regional Medical Center
|Goodyear, Arizona, United States, 85338 |
|Principal Investigator: Madappa N. N Kundranda, MD, PHD |
Western Regional Medical Center
||Madappa Kundranda, MD, PhD
||Western Regional Medical Center
No publications provided
||Madappa Kundranda, MD, MD, PhD, Western Regional Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 15, 2013
||May 9, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic