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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 supplement

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)

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 survival

Overall 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

Page last updated: August 23, 2015

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