Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC

NCT00755534 | Terminated Phase 2

• 1 other identifier: CT/05.31
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 10

Brief Summary

This phase II study will evaluate which is the best way to administer cetuximab after recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.

Conditions

Colorectal Cancer

Keywords

Metastatic colorectal cancer; Second line; Irinotecan; Cetuximab (Erbitux); Capecitabine (Xeloda)

Outcome Measures

Primary Outcomes (1)

• Time To Progression

  1 year

Secondary Outcomes (4)

• Objective Response Rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

• Toxicity profile

  Toxicity assessment on each chemotherapy cycle

• 1 year Survival and Overall Survival

  Probability of 1-year survival (%)

• Correlation of the molecular characteristics of the tumor with the clinical outcome

  Corralation after the end of chemotherapy

Study Arms (2)

1

EXPERIMENTAL

Irinotecan+Erbitux -\> XELOX+Erbitux

Drug: Irinotecan; Drug: Capecitabine; Drug: Cetuximab; Drug: Oxaliplatin

2

EXPERIMENTAL

XELOX+Erbitux -\>Irinotecan+Erbitux

Drug: Irinotecan; Drug: Capecitabine; Drug: Cetuximab; Drug: Oxaliplatin

Interventions

Irinotecan DRUG

Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression

Also known as: CPT-11, Campto

1; 2

Capecitabine DRUG

Capecitabine (p.o) 2000 mg/m2 (1000 mg/m2 x 2) on day 1-7 every 2 weeks until progression

Also known as: Xeloda

1; 2

Cetuximab DRUG

Cetuximab(IV) 500 mg/m2 on day 1 every two weeks until progression

Also known as: Erbitux

1; 2

Oxaliplatin DRUG

Oxaliplatin (I.V) 85 mg/m2 on day 1 every two weeks until progression

Also known as: Eloxatin, LoHP

1; 2

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed locally advanced or metastatic colorectal cancer
• Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
• ECOG performance status ≤ 2
• Age 18 - 72 years
• Patients who have had a CR, PR or SD after 1st line therapy based on Irinotecan+Bevacizumab
• Paraffin block from the primary tumor in order to perform tha mutational analysis of the KRAS gene
• Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit),renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
• Patients must be able to understand the nature of this study
• Written informed consent

You may not qualify if:

• Presence of central nervous system or brain metastases
• Pregnant or lactating woman
• Life expectancy \< 3 months
• Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow or in the field where the treatment target is located
• Peripheral neuropathy grade ≥2
• Known hypersensitivity to Erbitux
• Metastatic infiltration of the liver \>50%
• Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
• Active infection
• Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
• Psychiatric illness or social situation that would preclude study compliance

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (10)

University Hospital of Heraklion, Dep of Medical Oncology

Heraklion, Crete, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

State General Hospital of Larissa

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Capecitabine; Cetuximab; Oxaliplatin

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)

Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• John Souglakos, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 19, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

GR (10)