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An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Metastatic Pancreatic Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Metastatic Pancreatic Cancer


OBJECTIVES:

Primary

- Determine the antitumor activity of S-1 as second-line therapy, in terms of overall
response rate, in patients with metastatic pancreatic cancer previously treated with
gemcitabine.

Secondary

- Determine the duration of response, time to tumor progression, and overall survival
rate in patients treated with this drug.

- Correlate changes in CA 19-9 with antitumor activity of this drug in these patients.

- Determine the effect of this drug on the clinical benefit parameters in these patients.

- Determine the safety of this drug in these patients.

- Correlate plasma drug levels with safety and efficacy of this drug in these patients.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive oral S-1 twice daily on days 1-14. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 weeks for up to 6 months.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas

- Not amenable to curative radiotherapy or surgery

- Received first-line treatment with a gemcitabine-based regimen

- Measurable liver metastasis, defined as ≥ 1 unidimensionally measurable lesion ≥ 20
mm by conventional techniques OR ≥ 10 mm by spiral CT scan

- No symptomatic brain metastasis unless controlled by corticosteroids

- No uncontrolled ascites requiring drainage ≥ 2 times a week

- No leptomeningeal metastasis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT and AST ≤ 2.5 times ULN (5 times ULN if due to liver metastases)

Renal

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No myocardial infarction within the past 6 months

- No severe/unstable angina

- No New York Heart Association class III or IV congestive heart failure

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- Able to take oral medications

- No known hypersensitivity to fluorouracil

- No other active malignancies

- No known HIV- or AIDS-related illness

- No other severe acute or chronic medical condition, psychiatric condition, or
laboratory abnormality that would preclude study participation

- No chronic diarrhea, constipation (uncontrolled by laxatives), nausea, or vomiting

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

- No concurrent biologic response modifiers

Chemotherapy

- See Disease Characteristics

- At least 2 weeks since prior first-line gemcitabine-based regimen

- No other concurrent chemotherapy

- No fluoropyrimidine-group antineoplastic drugs within 7 days after completion of
study treatment

Endocrine therapy

- See Disease Characteristics

- No concurrent endocrine therapy

Radiotherapy

- At least 2 weeks since prior radiotherapy

- No prior radiotherapy to a target lesion unless the following are true:

- There is evidence of progressive disease after radiotherapy

- Target lesion is not the only site of measurable disease

- No concurrent radiotherapy

Surgery

- Not specified

Other

- More than 30 days since prior investigational agents

- No prior second-line therapy

- No concurrent investigational agents

- No concurrent drugs that may interact with S-1, including any of the following:

- Sorivudine

- Uracil

- Cimetidine

- Leucovorin calcium

- Dipyridamole

- Allopurinol

- Phenytoin

- Flucytosine

- No concurrent enrollment in another clinical study

- No other concurrent anticancer therapy

- No flucytosine within 7 days after completion of study treatment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall tumor response by CT (with contrast) of the chest, abdomen, and pelvis and physical exam at the end of every even course or every 6 weeks for up to 6 months

Safety Issue:

No

Principal Investigator

Dawn Buchanan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taiho Pharma U.S.A., Incorporated

Authority:

United States: Federal Government

Study ID:

CDR0000442387

NCT ID:

NCT00227604

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
Comprehensive Cancer InstituteHuntsville, Alabama  35801
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
U.T. Cancer Institute at University of Tennessee Medical CenterKnoxville, Tennessee  37920-2911
Palm Beach Cancer Institute - West Palm BeachWest Palm Beach, Florida  33401
Fountain Valley, California  92708
Lovelace Medical CenterAlbuquerque, New Mexico  87108
Florida Cancer Institute - New Port RicheyNew Port Richey, Florida  34655
Hematology Oncology Associates, PCAlbuquerque, New Mexico  87106
Associates in Oncology and Hematology - Medical Center DriveRockville, Maryland  20878
Cancer Center of IndianaNew Albany, Indiana  47150
Mary Crowley Medical Research Center at Sammons Cancer CenterDallas, Texas  75246
H. Clay Evans Johnson Cancer Center at Memorial HospitalChattanooga, Tennessee  37404
Compassionate Cancer Care Medical Group Incorporated - Fountain ValleyFountain Valley, California  92708
Western Hematology and Oncology Associates, PCLakewood, Colorado  80215
Eastern Oncology HematologyGreenville, North Carolina  27834
New Bern Cancer CareNew Bern, North Carolina  28560
Signal Point Hematology Oncology IncorporatedMiddletown, Ohio  45042
East Bay Medical Oncology Hematology AssociatesConcord, California  94520