Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

NCT ID: NCT00030732

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2008-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.

Detailed Description

OBJECTIVES:

• Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine.
• Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in 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 a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks. After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration.

Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine + Capecitabine

Gemcitabine + Capecitabine

Group Type: ACTIVE_COMPARATOR

Gemcitabine + Capecitabine

Intervention Type: DRUG

Gemcitabine + Capecitabine

Gemcitabine alone

Gemcitabine alone

Group Type: ACTIVE_COMPARATOR

Gemcitabine alone

Intervention Type: DRUG

Gemcitabine alone

Interventions

Gemcitabine + Capecitabine

Gemcitabine + Capecitabine

Intervention Type: DRUG

Gemcitabine alone

Gemcitabine alone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma
• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10.0 g/dL

Hepatic:

• Bilirubin no greater than 5 times normal
• AST/ALT no greater than 5 times normal
• Alkaline phosphatase no greater than 5 times normal

Renal:

• Creatinine clearance at least 30 mL/min

Gastrointestinal:

• No grade 2 or greater nausea or grade 1 or greater vomiting
• No medical condition that would interfere with taking oral medications or with gastrointestinal absorption (e.g., small bowel obstruction)

Other:

• No prior unanticipated severe reaction to fluoropyrimidine therapy
• No known hypersensitivity to fluorouracil
• No known dihydropyrimidine dehydrogenase deficiency
• No active infection
• No other serious concurrent systemic disorders that would preclude study participation
• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior capecitabine
• No prior chemotherapy for advanced pancreatic cancer
• At least 1 year since prior radiochemotherapy for pancreatic cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• See Chemotherapy
• At least 1 year since prior adjuvant radiotherapy for pancreatic cancer
• No concurrent radiotherapy

Surgery:

• Prior Whipple procedure or duodenal bypass allowed

Other:

• At least 1 month since prior investigational agents
• No concurrent sorivudine or its chemically related analogues (e.g., brivudine)
• No other concurrent anticancer or investigational drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central European Cooperative Oncology Group

OTHER

Sponsor Role: collaborator

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Herrmann, MD

Role: STUDY_CHAIR

Universitaetsspital-Basel

Werner Scheithauer, MD

Role: STUDY_CHAIR

Allgemeines Krankenhaus - Universitatskliniken

Locations

Allgemeines Krankenhaus der Stadt Wien

Vienna, , Austria

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, , Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, , Italy

Kantonspital Aarau

Aarau, , Switzerland

Saint Claraspital AG

Basel, , Switzerland

Universitatsspital-Basel

Basel, , Switzerland

Inselspital, Bern

Bern, , Switzerland

Spitalzentrum Biel

Biel, , Switzerland

Ratisches Kantons und Regionalspital

Chur, , Switzerland

Hopital Cantonal Universitaire de Geneve

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

Institut Central des Hopitaux Valaisans

Sion, , Switzerland

Regionalspital

Thun, , Switzerland

City Hospital Triemli

Zurich, , Switzerland

Oncology Institute of Southern Switzerland

Zurich, , Switzerland

UniversitaetsSpital

Zurich, , Switzerland

Countries

Austria; Israel; Italy; Switzerland

References

Bernhard J, Dietrich D, Glimelius B, Hess V, Bodoky G, Scheithauer W, Herrmann R. Estimating prognosis and palliation based on tumour marker CA 19-9 and quality of life indicators in patients with advanced pancreatic cancer receiving chemotherapy. Br J Cancer. 2010 Oct 26;103(9):1318-24. doi: 10.1038/sj.bjc.6605929. Epub 2010 Sep 28.

Reference Type: RESULT

PMID: 20877359 (View on PubMed)

Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Kohne CH, Mingrone W, Stemmer SM, Tamas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. doi: 10.1200/JCO.2007.15.6240.

Reference Type: RESULT

PMID: 18669454 (View on PubMed)

Hess V, Glimelius B, Grawe P, Dietrich D, Bodoky G, Ruhstaller T, Bajetta E, Saletti P, Figer A, Scheithauer W, Herrmann R. CA 19-9 tumour-marker response to chemotherapy in patients with advanced pancreatic cancer enrolled in a randomised controlled trial. Lancet Oncol. 2008 Feb;9(2):132-8. doi: 10.1016/S1470-2045(08)70001-9.

Reference Type: RESULT

PMID: 18249033 (View on PubMed)

Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Kohne CH, Mingrone W, Stemmer SM, Tamas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. doi: 10.1200/JCO.2006.09.0886.

Reference Type: RESULT

PMID: 17538165 (View on PubMed)

Gargiulo P, Dietrich D, Herrmann R, Bodoky G, Ruhstaller T, Scheithauer W, Glimelius B, Berardi S, Pignata S, Brauchli P. Predicting mortality and adverse events in patients with advanced pancreatic cancer treated with palliative gemcitabine-based chemotherapy in a multicentre phase III randomized clinical trial: the APC-SAKK risk scores. Ther Adv Med Oncol. 2019 Jan 2;11:1758835918818351. doi: 10.1177/1758835918818351. eCollection 2019.

Reference Type: RESULT

PMID: 30636977 (View on PubMed)

Other Identifiers

SWS-SAKK-44/00

Identifier Type: OTHER

Identifier Source: secondary_id

CECOG/PAN-1.3.001

Identifier Type: -

Identifier Source: secondary_id

EU-20142

Identifier Type: -

Identifier Source: secondary_id

SAKK 44/00

Identifier Type: -

Identifier Source: org_study_id