A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

NCT00660699 | Completed Phase 2 Results DMC

• 1 other identifier: 02-0580 / 201101866
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.

Conditions

Cholangiocarcinoma Cancer; Gallbladder Cancer; Pancreatic Cancer; Ampullary Cancer

Keywords

Cholangiocarcinoma; Gallbladder; Pancreatic; Ampullary; Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Severe Toxicities

  Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0

  1 month after completion of treatment (treatment lasts approximately 19 weeks)

Secondary Outcomes (6)

• Toxicities Associated With Treatment (Grade 1-2)

  30 days after completion of treatment (treatment lasts approximately 19 weeks)

• Toxicities Associated With Treatment (Grade 3-4)

  30 days after completion of treatment (treatment lasts approximately 19 weeks)

• Disease Free Survival (DFS) - Median

  Median follow-up was 24 months (range 3.2-97 months)

• Overall Survival (OS) - Median

  Median follow-up was 24 months (range 3.2-97 months)

• Overall Survival (OS)

  1 year

Study Arms (1)

Arm 1 (gemcitabine, docetaxel, 5FU, radiation)

EXPERIMENTAL

Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)

Drug: Gemcitabine; Drug: Docetaxel; Radiation: Radiation

Interventions

Gemcitabine DRUG

Also known as: Gemzar

Arm 1 (gemcitabine, docetaxel, 5FU, radiation)

Docetaxel DRUG

Also known as: Taxotere

Arm 1 (gemcitabine, docetaxel, 5FU, radiation)

Radiation RADIATION

Arm 1 (gemcitabine, docetaxel, 5FU, radiation)

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 biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
• Patients must be 18 years or older.
• Patients must have a NCI CTC Performance Status of 0-2.
• Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
• At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
• Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for \>5years
• Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
• Initial Required Laboratory Values:
• Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
• Serum creatinine should be ≤ 2 mg/dL.
• Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
• Serum transaminases should be ≤ 5-fold the institutional upper limits.
• Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
• Patients must be able to sign an informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Gallbladder Neoplasms; Pancreatic Neoplasms; Cholangiocarcinoma; Neoplasms

Interventions

Gemcitabine; Docetaxel; Radiation

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Physical Phenomena

Results Point of Contact

• Title: Benjamin Tan, M.D.
• Organization: Washington University School of Medicine

btan@dom.wustl.edu

314-362-5740

Study Officials

• Benjamin Tan, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 17, 2008
• Study Start: September 1, 2002
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2012
• Last Updated: May 27, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-05

Locations

US (1)