Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Prospective Phase I Study of Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283372
• Other study ID #: 201412038
• Status: Completed
• Phase: Phase 1
• Start date: January 21, 2015
• Est. completion date: April 18, 2019

Study information

• Verified date: June 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase I study to evaluate safety of gemcitabine with nab-paclitaxel and concurrent IMRT for locally advanced and borderline resectable pancreatic cancer. The goal of this study is to evaluate if a chemotherapy regimen that provides superior systemic efficacy may be safely delivered and enhance efficacy of tumor directed radiation therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 18, 2019
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered unresectable or borderline resectable based on institutional standardized criteria of unresectability or medical inoperability. Patients with and without regional adenopathy are eligible.

• Prior systemic chemotherapy allowed. It is anticipated and suggested that most patients enrolled on study will have received a minimum of approximately 2 months of systemic therapy according to routine institutional practices. The patient must also be felt by the treating medical oncologist and radiation oncologist to be a candidate for treatment with gemcitabine/nab-paclitaxel chemoradiotherapy.

• At least 18 years of age.

• ECOG performance status = 1

• Normal bone marrow and organ function as defined below:

• Absolute neutrophil count = 1,000/mcl

• Platelets = 100,000/mcl

• Hemoglobin = 9.0 g/dL

• Total bilirubin = 1.5 x ULN

• AST(SGOT)/ALT(SGPT) = 1.5 x IULN

• Serum creatinine = 1.5 mg/dL or calculated CrCL>60mL/min using Cockcroft and Gault formula

• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• Distant metastatic disease, including known brain metastases.

• History of prior malignancy is acceptable, but prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields is not allowed.

• Currently receiving any other investigational agents.

• Major surgery within 4 weeks prior to first study drug administration.

• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in the study.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.

• Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with gemcitabine and nab-paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• nab-Paclitaxel

• Gemcitabine

Radiation:
• Intensity modulated radiation

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	For the toxicity endpoint purposes of this trial, the patient will be followed from start of treatment until the patient completes 60 days of follow-up from the start of radiation therapy, has a dose-limiting toxicity (DLT), or is lost to follow-up.	Completion of toxicity follow-up for all patients (up to 32 months)
Secondary	Rate of conversion of patients with locally advanced pancreatic cancer or borderline resectable to resectable		1 year
Secondary	Local control (Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)	Local control is absence of tumor progression.; Response and progression will be evaluated in this study using the new international criteria proposed by the revised; Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).	1 year
Secondary	Progression-free survival (PFS)		1 year
Secondary	Overall survival (OS)		1 year
Secondary	Quality of life as measured by the EORTC QLQ-C30	The EORTC QLQ-C30 questionnaire will be utilized.	3 months after completion of treatment (up to 18 weeks)
Secondary	Frequency of RT adaptation based on MR guidance	The rate at which a change or adaptation to the patient's plan is made based on significant change in anatomy observed on localization MRI. This is defined as [#of treatment adaptations required]/[total # of RT treatments]	3 months after completion of treatment (up to 18 weeks)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine