Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Metastatic Pancreatic Cancer
Information source: City of Hope Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer
Intervention: Gemcitabine Hydrochloride (Drug); Paclitaxel Albumin-Stabilized Nanoparticle Formulation (Drug); Metformin Hydrochloride (Drug); Therapeutic Dietary Intervention (Dietary Supplement); Laboratory Biomarker Analysis (Other); Quality-of-Life Assessment (Other)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: City of Hope Medical Center Official(s) and/or principal investigator(s): Vincent Chung, Principal Investigator, Affiliation: City of Hope Medical Center
Summary
This pilot phase I trial studies the side effects of gemcitabine hydrochloride, paclitaxel
albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a standardized
dietary supplement in treating patients with pancreatic cancer that has spread from where it
started to other places in the body. Drugs used in chemotherapy, such as gemcitabine
hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation, work in different
ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Metformin hydrochloride, used for diabetes,
may also help kill cancer cells. Dietary supplements (curcumin, vitamin D, vitamin K2,
vitamin K1, B-6, high selenium broccoli sprouts, epigallocatechin gallate, L-carnitine,
garlic extract, genistein, zinc amino chelate, mixed toxopherols, ascorbic acid, D-limonene)
can block different targets in the cancer cell simultaneously and may slow down cancer
growth. Giving gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle
formulation, and metformin hydrochloride with a dietary supplement may work better in
treating patients with metastatic pancreatic cancer.
Clinical Details
Official title: Pilot Trial of Gemcitabine, Abraxane, Metformin and a Standardized Dietary Supplement (DS) in Patients With Metastatic Pancreatic Cancer
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Feasibility of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplementCompliance of the combination of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a dietary supplement (percent of patients who are fully compliant) 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)
Secondary outcome: Progression-free survivalOverall survival Time to treatment failure
Detailed description:
PRIMARY OBJECTIVES:
I. To assess the compliance, toxicity and feasibility of administering gemcitabine
(gemcitabine hydrochloride), Abraxane (paclitaxel albumin-stabilized nanoparticle
formulation), metformin (metformin hydrochloride), and the dietary supplement (DS).
SECONDARY OBJECTIVES:
I. To assess the response rate associated with this combination therapy in first line
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, pre-treatment biopsy samples, and stool 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. Courses 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must have a histologic diagnosis of pancreatic adenocarcinoma
- Patient must have metastatic disease
- Patients must not have received prior chemotherapy for metastatic disease;
gemcitabine based 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 fluorouracil or capecitabine are allowed as part of adjuvant
treatment and recurrence must be documented greater than 6 months from the completion
of chemotherapy; patients receiving chemoradiation therapy and/or 5-fluorouracil
based chemotherapy for locally advanced disease are eligible if metastatic disease is
documented and toxicities from chemotherapy have recovered to =< grade 1
- Computed tomography (CT)/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, so long as the dose is 1000 mg
per day (500 mg BID) or less; patients diagnosed with diabetes not taking metformin
are eligible and may start the clinical trial with continued glucose monitoring and
referral to an endocrinologist if the patient does not already have an
endocrinologist
- Patients allergic to eggs are not eligible
- Patients taking additional dietary/herbal supplements outside of this protocol and
refusing to stop are not eligible
- Patients requiring warfarin are not eligible
Locations and Contacts
City of Hope Medical Center, Duarte, California 91010, United States; Not yet recruiting Vincent Chung, Phone: 626-471-9200, Email: vchung@coh.org Vincent Chung, Principal Investigator
Additional Information
Starting date: January 2016
Last updated: July 7, 2015
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