A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

NCT00069108 | Completed Phase 3 Results

• 1 other identifier: NO16967
• Study Type: interventional
• Target: 627
• Locations: 19 countries
• Sites: 86

Brief Summary

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization

  Up to 3 years

Secondary Outcomes (10)

• Progression Free Survival Based on Independent Review Committee Assessment

  Up to 3 years

• Progression Free Survival Based on Treatment Analysis- Intent To Treat Population

  Up to 3 years

• Progression Free Survival Based on Treatment Analysis- Per Population

  Up to 3 years

• Best Overall Response, Investigators' Assessments

  Up to 3 years

• Best Overall Response, Independent Review Committee Assessment

  Up to 3 years

Study Arms (2)

XELOX

EXPERIMENTAL

Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m\^2 intravenous (IV) infusion over 2 hours (every 3 weeks \[Day 1\]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).

Drug: Oxaliplatin; Drug: capecitabine [Xeloda]

FOLFOX-4

ACTIVE COMPARATOR

Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin \[LV\] and 5-fluorouracil \[5-FU\] combination). Oxaliplatin was administered as an 85 mg/m\^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m\^2 over 2 hours followed by 5-FU, given as 400mg/m\^2 bolus injection over 2-4 minutes, and then as a 600 mg/m\^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m\^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).

Drug: 5 FU; Drug: Leucovorin; Drug: Oxaliplatin

Interventions

5 FU DRUG

As prescribed, in 2 week cycles

FOLFOX-4

Leucovorin DRUG

As prescribed, in 2 week cycles

FOLFOX-4

Oxaliplatin DRUG

As prescribed, in 3 week cycles

XELOX

capecitabine [Xeloda] DRUG

1000mg/m2 po bid on days 1-15 of each 3 week cycle

XELOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients \>=18 years of age;
• metastatic colorectal cancer;
• \>=1 target lesion;
• failed first-line chemotherapy with 5-fluorouracil and irinotecan.

You may not qualify if:

• previous treatment with oxaliplatin;
• progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
• \>=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (87)

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Bakersfield, California, 93309, United States

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Colorado Springs, Colorado, 80903, United States

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Washington D.C., District of Columbia, 20007-2197, United States

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Terre Haute, Indiana, 47802, United States

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St Louis, Missouri, 63136, United States

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Billings, Montana, 59101, United States

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Nyack, New York, 10960, United States

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Dallas, Texas, 75204, United States

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Brussels, 1000, Belgium

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Brussels, 1070, Belgium

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Ghent, 9000, Belgium

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Kortrijk, 8500, Belgium

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Mont-godinne, 5530, Belgium

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Edmonton, Alberta, T6G 1Z2, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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London, Ontario, N6A 4L6, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Ottawa, Ontario, K1H 1C4, Canada

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Saint Catherines, Ontario, L2R 2Z7, Canada

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Thunder Bay, Ontario, P7A 7T1, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Weston, Ontario, M9N 1N8, Canada

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Laval, Quebec, H7M 3L9, Canada

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Lévis, Quebec, G6V 3Z1, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2W 1S6, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Québec, Quebec, G1R 2J6, Canada

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Regina, Saskatchewan, S4T 7T1, Canada

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Split, 21000, Croatia

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Zagreb, 10000, Croatia

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Tampere, 36280, Finland

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Turku, 20520, Finland

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Avignon, 84082, France

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Bordeaux, 33075, France

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Bordeaux, 33076, France

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Chambray-lès-Tours, 37044, France

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Limoges, 87042, France

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Nîmes, 30029, France

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Pessac, 33604, France

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Rouen, 76031, France

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Tübingen, 72076, Germany

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Heraklion, 71110, Greece

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Thessaloniki, 56439, Greece

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Beersheba, 8410101, Israel

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Jerusalem, 91031, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 6423906, Israel

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Bergamo, 24128, Italy

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Cattolica, 47841, Italy

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Rimini, 47900, Italy

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Udine, 33100, Italy

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Bialystok, 15-073, Poland

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Krakow, 31-501, Poland

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Warsaw, 02-781, Poland

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Warsaw, 04-394, Poland

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San Juan, 00921-3201, Puerto Rico

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Belgrade, 11000, Serbia

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Bratislava, 831 01, Slovakia

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Ljubljana, 1000, Slovenia

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Cape Town, 7500, South Africa

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Durban, 4001, South Africa

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Pietermaritzburg, 3201, South Africa

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Port Elizabeth, 6001, South Africa

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Pretoria, 0001, South Africa

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Buchun, 420-021, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 133-792, South Korea

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Seoul, 137-040, South Korea

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Seoul, 138-736, South Korea

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Barcelona, 08907, Spain

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Leganés, 28911, Spain

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Madrid, 28035, Spain

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Madrid, 28041, Spain

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Palma de Mallorca, 07014, Spain

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Kueishan, Taiwan

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Tainan, 704, Taiwan

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Taipei, 104, Taiwan

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Denbigh, LL18 5UJ, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Merseyside, CH63 45Y, United Kingdom

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Preston, PR2 9HT, United Kingdom

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Leucovorin; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2003
• First Posted: September 18, 2003
• Study Start: July 1, 2003
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: April 1, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-03

Locations

SE (1); ES (5); PL (4); GB (4); GR (2); IT (4); CA (17); SL (1); FR (8); DE (1); IL (7); US (8); KR (6); BE (5); CR (2); FI (2); PR (1); ZA (5); TW (3)