Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

Stage IV Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01851174
• Other study ID #: WRMC 12-25
• Status: Terminated
• Phase: Phase 2
• First received: February 15, 2013
• Last updated: January 11, 2018
• Start date: February 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2018
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.

2. Patient has one or more radiographically measurable tumor.

3. Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).

4. Age = 18 years.

5. Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.

6. ECOG performance status 0 - 2 and an expected survival of at least 3 months.

7. Acceptable hematological parameters within 2 weeks of commencing study therapy as follows:

• Absolute neutrophil count (ANC) = 1.5 x 10^9/L

• Platelet count = 100 x 10^9/L

• Hemoglobin (Hgb) = 9g/dl

8. 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.

B. Hepatic: Bilirubin = 2.0 mg/ and ALT and AST = 1.5x the upper limit of normal.

C. Renal: Creatinine = 1.5 mg/dl and no other chronic kidney disease.

9. 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 ß-HCG within 7 days of study drug administration.

Exclusion Criteria:

1. Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.

2. Previous use of any chemotherapy or radiation therapy for metastatic disease.

3. 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).

4. Other significant active or chronic infection.

5. History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.

6. Pregnant or nursing females.

7. 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.

8. Major surgery, other than diagnostic surgery within 4 weeks of study entry.

9. Patient requires a legal authorized representative for consenting.

Related Conditions & MeSH terms

• Pancreatic Carcinoma Non-resectable
• Pancreatic Neoplasms
• Stage IV Pancreatic Cancer

Intervention

Drug:
• Gemcitabine
Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion
• nab-Paclitaxel
Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion

Locations

Country	Name	City	State
United States	Western Regional Medical Center	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival Based on Toxicity Profile of Adverse Events.	Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel	One year
Secondary	Progression Free Survival Time	Determine progression free survival time with this regimen	One year