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Pancreatic CancerPhase 1/2NCT00209677

Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

A Phase 1/2 study testing Gemcitabine and S-1 in people with Pancreatic Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

To assess the usefulness of Gemcitabine plus S-1 therapy based on the antitumor effect and survival period. By performing a phase I/II study of this combination in patients with inoperable or with postoperative pancreatic cancer. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gemcitabine and S-1
How many people
40 participants
Where
1 siteJapan
Study dates
Dec 2004to Dec 2007
Phase
Phase 1/2
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological diagnosis of pancreatic adenocarcinoma.
  • Measurable or assessable lesions(Except for Phase I).
  • Age: 20 ~ 75 years.
  • Kar-nofsky Performance Status (KPS) > 70.
  • No prior chemotherapy
  • No history of treatment with gemcitabine or S-1.
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  • No history of radiotherapy to the abdomen.
  • Oral intake of S-1 is possible.
  • Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and Neutrophil 2,000/mm3. Hb 9.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5 times the upper limit of normal (excluding liver metastasis). T-Bil 2.0 mg/dl. Creatinine within the upper limit of normal). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
  • Predicted survival for >3 months.
  • Able to give written informed consent.

Who cannot join

  • Severe pleural effusion or ascites.
  • Metastasis to the central nervous system (CNS).
  • Active gastrointestinal bleeding.
  • Active infection.
  • Liver cirrhosis
  • Uncontrolled ischemic heart disease.
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  • Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
  • Active multiple cancer.
  • Severe mental disorder.
  • Pregnancy, possible pregnancy, or breast-feeding.
  • Flucytosine treatment
  • Judged to be ineligible for this protocol by the attending physician.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)

    Sapporo, Hokkaido, 060-8638

Other trials in Japan

About this study

To assess the usefulness of Gemcitabine plus S-1 therapy based on the antitumor effect and survival period. By performing a phase I/II study of this combination in patients with inoperable or with postoperative pancreatic cancer.

Read the detailed description

A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV Pancreatic cancer given gemcitabine plus S-1. The usefulness of this regimens as 1st line therapy for pancreatic cancer was evaluated by the disease-free survival(DFS), median survival time (MST), incidence and severity of adverse event.

Being tested
Gemcitabine, S-1
Medical subject headings
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. Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.

  2. Determine the clinical response rate with Recommended dose in Phase II setting.

Secondary outcomes (2)

  1. Determine the clinical response rate of patients in Phase I setting.

  2. Determine the MST(Median Survival Time) and DFS(Disease Free Survival) in Phase II setting.

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Study completionDec 2007 (estimated)

Why it stopped: Unfortunately, other Phase III clinical Study (GEM+S-1 vs GEM vs S-1) have been started in Japan. h

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00209677
Sponsor's protocol ID
HGCSG0405
Other IDs
GEMS-1
Status last verified
Oct 2007
First submitted
13 Sep 2005
Last updated
1 Nov 2007
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gemcitabine and S-1 in people with Pancreatic Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. 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: paused, as of the sponsor's last update on 1 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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?

Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.. The study lists 2 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 NCT00209677.

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 1 Nov 2007.

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