Know Cancer

or
forgot password

A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer


OBJECTIVES:

- Compare the 1-year survival rate of patients with locally advanced or metastatic
pancreatic cancer treated with gemcitabine with or without capecitabine.

- Compare the median and 2-year survival rates and the objective response rates of
patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is an randomized, open-label, multicenter study. Patients are stratified
according to disease stage (locally advanced vs metastatic) and performance status (0 and 1
vs 2). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral
capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in
the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36,
and 43 during the first course. After a 1-week rest period, patients receive
gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28
days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1 year, and then annually
thereafter.

Patients are followed every 3 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed ductal adenocarcinoma of the pancreas

- Locally advanced or metastatic disease not amenable to curative surgical
resection

- Macroscopic residual disease after prior resection with histological
confirmation is allowed

- Unidimensionally measurable disease

- No intracerebral metastases or meningeal carcinomatosis

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- WHO 0-2

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC greater than 3,000/mm3

- Neutrophil count greater than 1,500/mm3

- Platelet count greater than 100,000/mm3

Hepatic:

- Bilirubin less than 2 mg/dL

Renal:

- Creatinine less than 2 mg/dL

- Creatinine clearance greater than 50 mL/min

Cardiovascular:

- No New York Heart Association class III or IV heart disease

- No uncontrolled angina pectoris

Other:

- No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the
cervix

- No other concurrent uncontrolled medical condition

- No other medical or psychiatric condition that would preclude study

- No known hypersensitivity to fluorouracil

- No dihydropyrimidine dehydrogenase deficiency

- No known malabsorption syndromes

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy (including preoperative or adjuvant) for this disease

- No other concurrent cytotoxic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy (including preoperative or adjuvant) for this disease

Surgery:

- See Disease Characteristics

Other:

- No prior investigational drugs (including preoperative or adjuvant) for this disease

- No other concurrent investigational drugs

- No concurrent dipyridamole or allopurinol

- No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm
only)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Survival at 1 year

Safety Issue:

No

Principal Investigator

Emily Owen

Investigator Affiliation:

Cancer Research UK

Authority:

United States: Federal Government

Study ID:

CRUK-GEM-CAP

NCT ID:

NCT00032175

Start Date:

April 2002

Completion Date:

May 2007

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • duct cell adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location