Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) for Pancreatic Adenocarcinoma

NCT01161186 | Completed Phase 1 DMC

• 1 other identifier: CC#10451
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate optimal dose and safety of the combination of Abraxane, gemcitabine, and Xeloda (capecitabine) (AGX) as first-line therapy in patients with metastatic pancreatic cancer.

Conditions

Pancreatic Neoplasms; Pancreatic Cancer; Adenocarcinoma

Keywords

pancreas; cancer; abraxane; metastatic; gemcitabine; capecitabine; adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• to establish the maximal tolerated dose (MTD) of the AGX combination in patients with previously untreated, metastatic pancreatic adenocarcinoma.

  Ongoing evaluation through sequential dose cohorts

Secondary Outcomes (2)

• To assess the safety profile of this combination (AGX) using NCI-CTCAE v.4 criteria.

  Ongoing evaluation for all patients throughout the course of treatment

• To obtain a preliminary assessment of the clinical efficacy of AGX as measured by time to tumor progression, overall survival, objective radiographic response (ORR), and CA 19-9 biomarker response

  Efficacy evaluations at 2-month intervals; patients followed for survival throughout lifetime.

Study Arms (1)

Nab-paclitaxel,Gemcitabine, and Capecitabine

EXPERIMENTAL

Drug: nab-paclitaxel, gemcitabine, capecitabine

Interventions

nab-paclitaxel, gemcitabine, capecitabine DRUG

{nab-paclitaxel: Intravenous, 100 to 150 mg/m2 over 30 minutes once per cycle.} {gemcitabine: Intravenous, 750 to 1000 mg/m2 at 10mg/m2/minute once per cycle.} {capecitabine: oral, 500 to 1000 mg/m2 b.i.d. 7 days per cycle}

Also known as: Abraxane, nanoparticle albumin bound paclitaxel, Xeloda, Gemzar

Nab-paclitaxel,Gemcitabine, and Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed pancreatic adenocarcinoma
• Stage IV disease (metastatic only)
• No prior systemic therapy for their diagnosis (except in adjuvant setting \> six months previously)
• ECOG performance score of 0-1
• At least 18 years of age
• Evidence of either or both of the following:
• RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)
• An elevated serum CA19-9 at baseline ( ≥ 2X ULN)
• Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.
• Adequate bone marrow function:
• ANC ≥ 1500/uL
• platelet count ≥ 100,000/uL
• hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 X ULN
• AST (SGOT) ≤ 2.5 X ULN

You may not qualify if:

• Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permissible as long as it was completed \> 6 months prior to the time of study enrollment.
• Inability to comply with study and/or follow-up procedures.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
• Presence of central nervous system or brain metastases.
• Life expectancy \< 12 weeks
• Pregnancy (positive pregnancy test) or lactation.
• Prior malignancy except for adequately treated basal 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 form of cancer from which the patient has been disease-free for 5 years.
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• Known, existing uncontrolled coagulopathy.
• Pre-existing sensory neuropathy \> grade 1.
• Major surgery within 4 weeks of the start of study treatment, without complete recovery.
• Concurrent/pre-existing use of coumadin.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Celgene Corporation: collaborator

Study Sites (2)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84115, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma; Neoplasms; Neoplasm Metastasis

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine; Capecitabine; Albumin-Bound Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations

Study Officials

• Andrew Ko, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 13, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (2)