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Pancreatic Cancer

Combination Chemotherapy + Radiation + Surgery for Localized Pancreatic Cancer (FHCRC-6511)
A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients with Locally Advanced, Resectable Pancreatic Adenocarcinoma
Status Conditions Phase Study ID
Closed Pancreatic Cancer Phase II FHCRC-6511
NCT00609336
Summary

The current, standard treatment for pancreatic cancer is surgery to remove the cancer. The purpose of this study is to determine whether or not adding chemotherapy and radiation treatments to the standard treatment of surgery will delay (or stop) the return of pancreatic cancer.

Treatment on the study takes place as follows:

1. Chemotherapy: Received during the first 2 months.

2. Chemotherapy with radiation (called "chemoradiotherapy"): Received during the next 2 weeks.

3. Surgery: (Surgery is a standard treatment for pancreatic cancer.) The surgery will take place 2 - 6 weeks after finishing chemoradiotherapy.

4. Additional chemotherapy: Chemotherapy will start again some time between 4 - 10 weeks after surgery and will last for about 4 months.

Completing all of the treatment on this study will take about 33 - 45 weeks (8 - 11 months),

Subjects will receive chemotherapy and radiation treatments at the Seattle Cancer Care Alliance outpatient clinic. Subjects will be hospitalized at the University of Washington Medical Center for surgery.

We will also follow-up with subjects after they go off active study treatment. We may call subjects on the phone or contact their regular doctors.


Investigator
Andrew Coveler, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

1. Subjects must be 18 years of age or older.

2. Subjects must have a diagnosis of localized pancreatic cancer. (Histologically or cytologically confirmed diagnosis of localized, resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0. Resectability is determined by the treating surgeon.)

3. Subject has not been previously treated for pancreatic cancer.

4. Subjects must be able to take care of themselves, and must be able to swallow oral medication.

5. Women of childbearing potential must not be pregnant or breastfeeding.

6. Men and women of childbearing potential must be willing to use effective contraception while on treatment.

7. Subjects must have adequate white and red blood cell counts, and adequate organ function (by laboratory test).

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Receiving any other investigational drugs during this study.

- Pancreatic cancer that cannot be surgically removed, as determined by the treating physician.

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the following drugs: gemcitabine, docetaxel, capecitabine, oxaliplatin or other agents used in the study.

- Received prior drug or radiation treatment for pancreatic cancer. 

- Any condition, medical or other, that would limit compliance with study requirements.

- Pregnant or breast-feeding.

- HIV-positive and receiving combination anti-retroviral therapy (excluded from the study because of possible pharmacokinetic interactions with the study medications).

Other exclusion criteria may apply.

Last Updated
September 27, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.