GTX-RT in Borderline Resectable Pancreatic Cancer

NCT01754623 | Terminated Phase 2 Results

• 1 other identifier: MCC-16932
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreas; Pancreatic; Neoplasms; Stereotactic; Radiosurgery; Borderline; Resectable; Gastrointestinal; Gemcitabine; Capecitabine; Fluorouracil; Docetaxel; SBRT; GTX Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Margin-negative (R0) Resection Rate

  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.

  Up to 3 years

Secondary Outcomes (2)

• Progression-Free Survival (PFS) at Three Years

  3 years

• Overall Survival (OS) Rate

  12 months

Study Arms (1)

Chemotherapy Followed by Radiation Treatment

EXPERIMENTAL

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.

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

Interventions

Capecitabine DRUG

Treatment will begin with the first round of chemotherapy. Each round of chemotherapy will take 21 days. Each round or cycle will start with participants taking capecitabine pills. Participants will take tablets of capecitabine (Xeloda®) twice per day for 14 days followed by 7 days without capecitabine.

Also known as: Xeloda®

Chemotherapy Followed by Radiation Treatment

Gemcitabine DRUG

On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. First, this will consist of placing gemcitabine (Gemzar®) in a bag of fluid and giving it by vein over 30 minutes.

Also known as: Gemzar®

Chemotherapy Followed by Radiation Treatment

Docetaxel DRUG

On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. After the gemcitabine, participants will receive docetaxel (Taxotere®) in a bag of fluid over 1 hour.

Also known as: Taxotere®

Chemotherapy Followed by Radiation Treatment

Stereotactic body radiation therapy (SBRT) RADIATION

30/40 Gy to pancreatic tumor/area of borderline resectability

Also known as: SBRT

Chemotherapy Followed by Radiation Treatment

Restaging review after radiation OTHER

After radiation, participants will be re-evaluated for surgery. Patients who have Complete Response (CR), Partial Response (PR) or stable disease (SD) will proceed with surgical exploration and resection provided they are suitable fit for surgery in the judgment of the surgical oncologist. Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT). If no surgery: then chemotherapy. If surgery: chemotherapy will be given based on response.

Chemotherapy Followed by Radiation Treatment

Surgery PROCEDURE

Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery. After surgery, chemotherapy will be given based on response.

Chemotherapy Followed by Radiation Treatment

5-Fluorouracil DRUG

Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT).

Chemotherapy Followed by Radiation Treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Strom T, Hoffe SE, Fulp W, Frakes J, Coppola D, Springett GM, Malafa MP, Harris CL, Eschrich SA, Torres-Roca JF, Shridhar R. Radiosensitivity index predicts for survival with adjuvant radiation in resectable pancreatic cancer. Radiother Oncol. 2015 Oct;117(1):159-64. doi: 10.1016/j.radonc.2015.07.018. Epub 2015 Jul 30.

  PMID: 26235848 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Capecitabine; Gemcitabine; Docetaxel; Radiosurgery; Surgical Procedures, Operative; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Limitations and Caveats

The study only accrued 9 (of planned 35) participants. It was not possible to collect adequate pre-treatment tissue for radiosensitivity index (RSI) analysis, pre-treatment. The study was terminated before planned completion.

Results Point of Contact

• Title: Ravi Shridhar, M.D., Ph.D.
• Organization: Florida Hospital Orlando (Formerly at Moffitt Cancer Center)

ravi.shridhar.md@flhosp.org

407-303-5857

Study Officials

• Ravi Shridhar, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 13, 2015
• Results First Posted: August 13, 2015

Record last verified: 2015-06

Locations

US (1)