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AzTrials

Extrahepatic Bile Duct CancerPhase 1NCT00544193

Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer

A Phase 1 study testing gemcitabine hydrochloride, polymerase chain reaction and immunohistochemistry staining method in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by City of Hope Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
gemcitabine hydrochloride, polymerase chain reaction and immunohistochemistry staining method
Type of treatment
Surgery or procedure
How many people
16 participants
Where
No sites listed yet
Study dates
Dec 1997to Aug 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of any of the following upper gastrointestinal malignancies:
  • Localized pancreatic adenocarcinoma
  • Stage I, II, or III disease
  • Parapancreatic node involvement and locally recurrent disease allowed
  • Locally advanced biliary, gallbladder, or ampullary adenocarcinoma
  • Stage II, III, or locally recurrent disease
  • Histologically confirmed locally advanced gastric adenocarcinoma
  • T3, T4, or node positive OR locally recurrent disease
  • Histologically confirmed locally advanced duodenal cancer
  • Stage II or III disease
  • Locally advanced, but unresectable cancers may be included on protocol if appropriate for intraoperative radiotherapy (IORT)
  • Other histologies may be considered for this protocol except for lymphoma, sarcoma, or neuroendocrine tumors
  • Patients with evidence of metastatic disease are eligible if there is significant local disease warranting surgery and IORT

PATIENT CHARACTERISTICS:

  • Karnofsky performance status > 60%
  • Life expectancy > 4 months
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Serum creatinine < 2.0 mg/dL
  • ALT < 3 x normal
  • Bilirubin < 2 x normal
  • Must be able to give voluntary informed consent
  • No severe intercurrent illness that would make the patient inappropriate for laparotomy or otherwise inappropriate for treatment on protocol
  • Prior history of malignancy allowed

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C)
  • Prior gemcitabine hydrochloride allowed

About this study

Official title: Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy in treating patients with locally advanced upper gastrointestinal cancer.

Read the detailed description

OBJECTIVES:

  • To determine the feasibility of combining preoperative or intraoperative gemcitabine hydrochloride with intraoperative radiotherapy.
  • To determine the tolerance of gemcitabine hydrochloride given concurrently with external-beam radiotherapy.
  • To measure biochemical parameters in tumors that may correlate with the effectiveness of therapy.

OUTLINE: Patients receive gemcitabine hydrochloride IV 12-18 hours prior to planned surgery. All patients then undergo an exploratory laparotomy that may include tumor debulking, Whipple-type resection (pancreaticoduodenectomy), total pancreatectomy, gastrojejunostomy, total or partial gastrectomy, or cholecystectomy and en bloc resection depending on the extent of the disease. Patients with no metastatic disease beyond regional lymph nodes also undergo intraoperative radiotherapy.

Beginning 2-6 weeks after surgery, patients undergo external-beam radiotherapy (EBRT) once a day 5 days a week for up to 7 weeks. Patients also receive escalating doses of gemcitabine hydrochloride IV at the beginning of each week of EBRT.

Patients undergo tissue sample collection periodically for correlative studies. Samples are analyzed for thymidylate synthase (TS), ribonucleotide reductase (RR), excision-repair-cross-complementing (ERCC)-1 protein, deoxycytidine kinase mRNA. Biopsy tissues are also analyzed for gemcitabine triphosphate, dATP, and dCTP content. p53 status is assessed via immunohistochemistry and mRNA levels via quantitative polymerase chain reaction (PCR).

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then once a year thereafter.

Keywords
adenocarcinoma of the extrahepatic bile duct, adenocarcinoma of the gallbladder, adenocarcinoma of the pancreas, adenocarcinoma of the stomach, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, localized gallbladder cancer, recurrent gallbladder cancer, unresectable gallbladder cancer, recurrent gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, stage I gastric cancer, recurrent pancreatic cancer, small intestine adenocarcinoma
Medical subject headings
Bile Duct Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

  2. Tolerance

  3. Measurement of biochemical parameters in tumors that may correlate with the effectiveness of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2007 (estimated)
  2. Study startDec 1997
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00544193
Sponsor's protocol ID
97087
Other IDs
P30CA033572, CHNMC-97087
Status last verified
Jun 2015
First submitted
13 Oct 2007
Last updated
8 Jun 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing gemcitabine hydrochloride, polymerase chain reaction and immunohistochemistry staining method in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by City of Hope Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00544193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.

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