GTX-RT in Borderline Resectable Pancreatic Cancer

Phase 2

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: Capecitabine; Drug: Gemcitabine; Drug: Docetaxel; Radiation: Stereotactic body radiation therapy (SBRT); Other: Restaging review after radiation; Procedure: Surgery; Drug: 5-Fluorouracil

• Registration Number: NCT01754623
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed completely.

Detailed Description

Investigators plan to conduct a prospective pilot phase II trial of GTX-SBRT as neoadjuvant treatment of borderline resectable pancreatic cancer. After informed consent, pretreatment pancreatic tumor tissues will be collected and immediately frozen at the time of staging endoscopic ultrasound (EUS). Ribonucleic acid (RNA) will be extracted from tumor specimens and run on microarray analysis to determine radiosensitivity index score. Borderline resectable (BR) patients will be treated with 3 cycles of GTX chemotherapy followed by SBRT. They will be restaged and evaluated for resectability 3 to 4 weeks later. Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery.

Study Timeline

• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Study Start: 2013-02
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2015-06
• Results First Submitted: 2015-06-17
• Results First Submitted QC: 2015-08-06
• Last Update Submitted: 2015-08-06
• Results First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as:

  • circumferential tumor abutment with the superior mesenteric vein (SMV) or portal vein (PV) or SMV/PV confluence over </= 180°
  • circumferential tumor abutment with the superior mesenteric artery (SMA) over </= 180°
  • Short segment encasement (360°) of the PV or SMV that is amenable to partial vein resection and reconstruction
  • encasement of the gastroduodenal artery up to the origin of the hepatic artery

• Patients must have measurable disease

• No previous chemotherapy or radiation to the pancreas

• Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%)

• Patients must have normal organ and marrow function as defined below:

  • leukocytes >/= 3,000/μL
  • absolute neutrophil count >/= 1,000/ μL
  • platelets >/= 100,000/ μL
  • creatinine within normal institutional limits (ULN)
  • total bilirubin will allow for 2x the upper limit of the institution. Patients may have biliary stents or drains to lower total bilirubin to this range.

• Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential). Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration.

• Ability to understand and the willingness to sign a written informed consent document

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Exclusion Criteria

• Patients with metastatic disease are ineligible.
• Patients who have had prior chemotherapy for pancreatic adenocarcinoma
• Patients who have received prior radiation to an abdominal site are not eligible.
• Patients with peripheral neuropathy >/= grade 2
• Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel), other drugs formulated with polysorbate 80, gemcitabine, or capecitabine
• Patients may not be receiving any other investigational agents.
• ECOG Performance Status 3-4
• Pregnant or breast-feeding women are excluded from this study because gemcitabine,capecitabine, and docetaxel are Class D agents with the potential for teratogenic or abortifacient effects.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy Followed by Radiation Treatment	Surgery	Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
Chemotherapy Followed by Radiation Treatment	Stereotactic body radiation therapy (SBRT)	Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
Chemotherapy Followed by Radiation Treatment	Restaging review after radiation	Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
Chemotherapy Followed by Radiation Treatment	Gemcitabine	Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
Chemotherapy Followed by Radiation Treatment	Capecitabine	Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
Chemotherapy Followed by Radiation Treatment	Docetaxel	Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
Chemotherapy Followed by Radiation Treatment	5-Fluorouracil	Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.

Primary Outcome Measures

Name	Time	Method
Margin-negative (R0) Resection Rate	Up to 3 years	R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) Rate	12 months	OS at time of analysis, calculated from date of enrollment to date of death from any cause.
Progression-Free Survival (PFS) at Three Years	3 years	PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States