Chemoradiation +Gemcitabine +Continuous 5-FU (Fluorouracil) Followed by High Dose Brachytherapy/Stereotactic Radiation Boost in Locally Advanced Intra/Extrahepatic Cholangiocarcinoma

NCT00983541 | Terminated Phase 2 Results DMC

• 1 other identifier: HCI35306
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment in terms of toxicity. If toxicity is not acceptable, the treatment is not feasible. Primary Objectives

• To establish a preliminary assessment whether toxicity rates are acceptable in patients with locally advanced intra or extrahepatic cholangiocarcinoma when treated with a regimen of gemcitabine every two weeks and continuous fluorouracil (5-FU) given concurrently with external beam radiation therapy to a total dose of 45 gray(Gy), followed by a brachytherapy or Stereotactic Body Radiation Therapy(SBRT) boost. Secondary Objectives
• To evaluate the overall survival rate, progression free survival rate, tumor response rate, local control rate and the rate of distant metastases following gemcitabine and continuous 5-FU concurrent with radiation therapy in patients with locally advanced intra or extrahepatic cholangiocarcinoma.
• To evaluate the rate at which patients with unresectable extrahepatic cholangiocarcinoma become resectable following gemcitabine and radiation therapy.

Conditions

Cancer

Keywords

intra or extrahepatic cholangiocarcinoma; liver cancer; liver; HCC; EHCC

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Toxicity Treated With Gemcitabine Every Two Weeks & 5-FU Given Concurrently With External Beam Radiation Therapy , Followed by Brachytherapy or SBRT Boost.

  Toxicity was assessed for each patient over the course of the study treatment and follow-up stage which together lasted 9 months. Only one patient was enrolled.

Secondary Outcomes (6)

• Evaluate Overall Survival Ratefollowing Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC

  9 months

• Evaluate the Rate at Which Patients With Unresectable Extrahepatic Cholangiocarcinoma Become Resectable Following Gemcitabine and Radiation Therapy.

  9 months

• Evaluate Progression Free Survival Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC

  9 months

• Evaluate Tumor Response Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC

  9 months.

• Evaluate Local Control Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC

  9 months

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Drug: Fluorouracil (5-FU); Radiation: Brachytherapy or SBRT (Stereotactic body radiation therapy); Drug: Gemcitabine

Interventions

Fluorouracil (5-FU) DRUG

5-FU Injection,USP (GeneraMedix Inc.) is effective in palliative management of carcinoma (colon, rectum, breast, stomach, pancreas) FDA approved in 1962-NDA (New Drug Application)012209. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy

Also known as: (5-FU)

All patients

Brachytherapy or SBRT (Stereotactic body radiation therapy) RADIATION

Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).

Also known as: brachytherapy or stereotactic body radiation therapy boost

All patients

Gemcitabine DRUG

Pancreatic:Indicated as first line treatment for patients with locally advanced (nonresectable Stage II or III) or metastatic(Stage IV) pancreatic adenocarcinoma. Ovarian:Gemzar with carboplatin is indicated for treatment of patients with advanced ovarian cancer relapsed 6 months after plat-based therapy. Breast:Gemzar with paclitaxel is indicated for first line treatment of patients with metastatic breast cancer after failed anthracycline-containing adjuvant chemotherapy, unless anthracyclines. Non-small cell lung cancer(NSCLC):Gemzar is indicated with cisplatin for first line treatment of patients with inoperable, local advanced (Stage IIIA/IIIB), metastatic (Stage IV) NSCLC.

Also known as: Gemzar

All patients

Eligibility Criteria

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

You may qualify if:

• Patients over age 18
• Intra or extrahepatic cholangiocarcinoma confirmed by biopsy/brushings, biliary aneuploidy demonstrated by FISH, or elevated CA 19-9 greater than 100 ng/mL in the presence of a radiographic malignant stricture
• Deemed surgically unresectable by a surgical oncologist
• Malignant disease encompassable within a single radiation field
• ECOG 0-2
• Laboratory values: Hemoglobin ≥ 8.0 (can be transfused to attain this value), Granulocytes \> 1,500, platelets \> 100,000/ul

You may not qualify if:

• Chemotherapy within one month of starting radiation therapy
• Previous abdominal radiotherapy
• Uncontrolled infection or severe active comorbid disease
• Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
• Distant metastatic disease (outside regional lymph nodes)
• Pregnancy or lactating women

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms; Cholangiocarcinoma; Liver Neoplasms

Interventions

Fluorouracil; Brachytherapy; Radiosurgery; Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Results Point of Contact

• Title: Christopher Anker, MD
• Organization: Huntsman Cancer Institute

candace.larson@hci.utah.edu

801-213-4241

Study Officials

• Christopher Anker, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: September 22, 2009
• First Posted: September 24, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 19, 2015
• Results First Posted: August 19, 2015

Record last verified: 2015-07

Locations

US (1)