Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery
Keywords
Abstract
Description
PRIMARY OBJECTIVES:
I. To assess the compliance, toxicity and feasibility of administering gemcitabine hydrochloride (gemcitabine), nab-paclitaxel (abraxane), metformin hydrochloride (metformin), and the dietary supplement (DS).
SECONDARY OBJECTIVES:
I. To assess the response rate associated with this combination therapy in pancreatic cancer patients.
II. To assess the progression-free survival and overall survival of all patients who start protocol therapy, and describe the outcomes based on measures of compliance during the lead-in week, and compliance with supplement during chemotherapy.
III. To collect and analyze peripheral blood and pre-treatment biopsy samples for an exploratory analysis of biological correlatives.
IV. To assess quality of life utilizing the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire.
OUTLINE:
Patients receive gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) on days 1, 8, and 15. Patients also receive metformin hydrochloride orally (PO) twice daily (BID) starting day -6 and dietary supplement PO BID starting day -3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
Dates
| Last Verified: | 05/31/2019 |
| First Submitted: | 01/05/2015 |
| Estimated Enrollment Submitted: | 01/06/2015 |
| First Posted: | 01/11/2015 |
| Last Update Submitted: | 06/25/2019 |
| Last Update Posted: | 06/27/2019 |
| Actual Study Start Date: | 12/31/2015 |
| Estimated Primary Completion Date: | 07/31/2019 |
| Estimated Study Completion Date: | 07/31/2019 |
Condition or disease
Intervention/treatment
Drug: Treatment (gemcitabine, Abraxane, metformin, DS)
Drug: Treatment (gemcitabine, Abraxane, metformin, DS)
Drug: Treatment (gemcitabine, Abraxane, metformin, DS)
Dietary Supplement: Treatment (gemcitabine, Abraxane, metformin, DS)
Other: Treatment (gemcitabine, Abraxane, metformin, DS)
Other: Treatment (gemcitabine, Abraxane, metformin, DS)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Treatment (gemcitabine, Abraxane, metformin, DS) Patients receive gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15. Patients also receive metformin hydrochloride PO BID starting day -6 and dietary supplement PO BID starting day -3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Drug: Treatment (gemcitabine, Abraxane, metformin, DS) Given IV |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Patients must have a histologic diagnosis of pancreatic adenocarcinoma - Patient must have unresectable disease - Patients must not have received prior chemotherapy except for the following circumstances; gemcitabine and capecitabine chemotherapy given in the adjuvant setting is allowed if the recurrence is greater than 6 months from the completion of chemotherapy; radiation sensitizing doses of 5-fluororuracil or capecitabine are allowed as part of adjuvant treatment and recurrence must be documented greater than 6 months from the completion of adjuvant therapy - Computed tomography (CT) or magnetic resonance imaging (MRI) scan must be obtained within 4 weeks prior to study entry - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count > 1,500/mcl - Platelet count > 100,000/mcl - Creatinine < 1.4 mg/dl and/or a measured creatinine clearance > 60 cc/min - Bilirubin < 1.4 mg/dl - Alanine aminotransferase (ALT), aspartate aminotransferase (AST) no greater than 3.0 times the upper limit of normal - Patients currently being treated for severe infections or who are recovering from major surgery or other intercurrent illnesses are ineligible until recovery is deemed complete by the investigator - Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - Patients must be able to swallow pills and must not have malabsorption problems or ongoing nausea and vomiting that would affect oral treatment - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years - Patients currently taking metformin will be eligible - Patients allergic to eggs are not eligible - Patients taking additional dietary/herbal supplements (excluding Senekot) outside of this protocol and refusing to stop are not eligible - Patients requiring warfarin are not eligible |
Outcome
Primary Outcome Measures
1. Feasibility of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement [Up to 24 months]
2. Compliance of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (percent of patients who are fully compliant) [Up to 24 months]
3. Toxicity of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (National Cancer Institute Common Terminology for Adverse Events criteria version 4) [Up to 24 months]
Secondary Outcome Measures
1. Progression-free survival [Up to 24 months]
2. Overall survival [Up to 24 months]
3. Time to treatment failure [Up to 24 months]
Other Outcome Measures
1. Analysis of biological correlates (Peripheral blood will be evaluated) [Up to 24 months]
2. Quality of life, assessed using the FACT-G questionnaire [Up to 24 months]
