Adjuvant Xeloda Plus Eloxatin +/- Avastin After Radical Resection of Liver Metastasis of Colorectal Cancer

NCT00394992 | Terminated Phase 3 DMC

• 1 other identifier: HEPATICA
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate whether the addition of the new anti-cancer drug bevacizumab (Avastin) to the combination of the chemotherapeutic agents capecitabine (Xeloda) and oxaliplatin (Eloxatin) reduces (slows down) the recurrence of metastatic disease after a radical resection of liver metastases in patients with colorectal cancer.

Conditions

Colorectal Cancer; Liver Metastases

Keywords

Colorectal cancer; Liver metastasis; Radical resection; Adjuvant therapy; Bevacizumab; Capecitabine; Oxaliplatin; Hepatica

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival, defined as the percentage of disease free patients 3 year after randomisation.

  study duration

Secondary Outcomes (1)

• Overall survival, defined as the percentage of patients alive 5 year after randomisation.

  study duration

Study Arms (2)

1 oxaliplatin+capecitabine

ACTIVE COMPARATOR

postoperatively oxaliplatin 130 mg/m2 i.v. day 1 plus capecitabine 1000 mg/m2 b.i.d. on day 1-14, q3w

Drug: oxaliplatin+capecitabine

2 oxaliplatin+capecitabine+bevacizumab

EXPERIMENTAL

postoperatively oxaliplatin 130 mg/m2 i.v. day 1 plus bevacizumab 7.5 mg/kg on day 1 plus capecitabine 1000 mg/m2 b.i.d. on day 1-14, q3w

Drug: Oxaliplatin+capecitabine+bevacizumab

Interventions

oxaliplatin+capecitabine DRUG

postoperatively oxaliplatin 130 mg/m2 i.v. day 1 plus capecitabine 1000 mg/m2 b.i.d. on day 1-14, q3w

1 oxaliplatin+capecitabine

Oxaliplatin+capecitabine+bevacizumab DRUG

postoperatively oxaliplatin 130 mg/m2 i.v. day 1 plus bevacizumab 7.5 mg/kg on day 1 plus capecitabine 1000 mg/m2 b.i.d. on day 1-14, q3w

2 oxaliplatin+capecitabine+bevacizumab

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent obtained prior to any study-specific procedures.
• Age ≥ 18 years.
• Liver metastases radically resected (R0 resection).
• Study medication started ≥4 and ≤ 8 weeks post liver surgery.
• Histologically confirmed liver metastasis of colorectal cancer after surgery.
• ECOG performance status 0 or 1.
• Adequate hematology: ANC ≥1.5 x 109/L, platelets ≥100 x 109/L, Hb ≥5.5 mmol/L, INR ≤ 1.5, APTT \< 1.5 X UNL.
• Adequate biochemistry: total bilirubin ≤1.5 UNL, ASAT and ALAT ≤2.5 x UNL, alkaline phosphatase ≤2.5 x UNL, serum creatinine ≤1.5 UNL.
• Urine dipstick \<2+ for protein.

You may not qualify if:

• Extrahepatic metastatic disease.
• Prior adjuvant chemotherapy given \<6 months prior to detection of the liver metastases.
• Prior non colorectal malignancies.
• Bleeding diathesis or coagulation disorders or the need for full-dose anticoagulation.
• Major surgical procedure \<4 weeks prior to start of study treatment.
• Females with a positive pregnancy test (within 14 days before treatment start) .
• Lactating women.
• Fertile women (\<2 years after last menstruation) and women of childbearing potential not willing to use effective means of contraception.
• History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.
• Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents (≤6 months prior to randomization), myocardial infarction (≤1 year prior to randomization), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.
• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
• Known peripheral neuropathy, including oxaliplatin induced neuropathy \> grade Absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible.
• Organ allografts requiring immunosuppressive therapy.
• Serious, non-healing wound, ulcer, or bone fracture.
• Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.

Sponsors & Collaborators

• Dutch Colorectal Cancer Group: lead
• Sanofi: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Universitair Medisch Centrum Utrecht

Utrecht, 3508 GA, Netherlands

Location

Related Publications (1)

• Snoeren N, Voest EE, Bergman AM, Dalesio O, Verheul HM, Tollenaar RA, van der Sijp JR, Schouten SB, Rinkes IH, van Hillegersberg R. A randomized two arm phase III study in patients post radical resection of liver metastases of colorectal cancer to investigate bevacizumab in combination with capecitabine plus oxaliplatin (CAPOX) vs CAPOX alone as adjuvant treatment. BMC Cancer. 2010 Oct 11;10:545. doi: 10.1186/1471-2407-10-545.

  PMID: 20937118 DERIVED

Related Links

• Websites Dutch Colorectal Cancer Group
• University Medical Center Utrecht

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Richard van Hillegersberg, MD PhD

  Universitair Medisch Centrum Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 2, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

NL (1)