Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer

NCT00950820 | Terminated Phase 2 DMC

• 1 other identifier: AIO KRK 0107
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this interventional study is to investigate whether there is evidence that panitumumab in combination with XELOX (capecitabine plus oxaliplatin) chemotherapy will safely increase progression-free survival, above that of XELOX alone in subjects with KRAS wild-type metastatic colorectal cancer who have not responded to or progressed after first line therapy with irinotecan and a fluoropyrimidine. Further Objectives Exploratory objectives may include investigation of potential correlations between the treatment regimen and epidermal growth factor receptor (EGFR) expression, detection of the functional genetic polymorphisms of the EGFR gene, EGFR gene amplification (FISH), EGFR downstream protein and gene expression parameters, proteomics and epigenetics.

Conditions

Colorectal Neoplasms

Keywords

Open-label; Phase-II-Study; Randomized; Metastatic; Colorectal; Cancer; Panitumumab; Vectibix®; second-line-treatment; KRAS

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate at 6 months for subjects with KRAS wild-type tumours

  6 months

Secondary Outcomes (9)

• PFS

  end of study

• Objective-response-rate

  end of study

• Disease-control-rate

  end of study

• Time-to-response

  end of study

• time-to-progression

  end of study

Study Arms (3)

Panitumumab + XELOX

EXPERIMENTAL

KRAS mutational status wild-type: Panitumumab plus Oxaliplatin and Capecitabine (XELOX)

Drug: Oxaliplatin, Capecitabine, Panitumumab

XELOX (KRAS mutational status wt)

OTHER

KRAS mutational status wild-type: Oxaliplatin and Capecitabine (XELOX)

Drug: Oxaliplatin, Capecitabine

XELOX (KRAS mutational status mutant)

OTHER

KRAS mutational status mutant: Oxaliplatin and Capecitabine (XELOX)

Drug: Oxaliplatin, Capecitabine

Interventions

Oxaliplatin, Capecitabine, Panitumumab DRUG

Panitumumab at a dose of 9 mg/kg BW every three weeks will be administered on day 1 of each cycle just prior to administration of chemotherapy. The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15.

Panitumumab + XELOX

Oxaliplatin, Capecitabine DRUG

The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15.

XELOX (KRAS mutational status mutant); XELOX (KRAS mutational status wt)

Eligibility Criteria

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

You may qualify if:

• Male or female patients aged 18 years or more, with histologically or cytologically-confirmed and radiologically-measurable metastatic colorectal cancer.
• One prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine and irinotecan based chemotherapy. Subjects must have disease progression (as assessed by the investigator) and must be no candidates for primary metastasectomy.
• Measurable disease according to RECIST 1.1 guidelines. All sites of disease must have been evaluated within 28 days prior to registration / randomization, and diagnosed by the investigator.
• Liver and kidney function within defined ranges and sufficient bone marrow reserve.

You may not qualify if:

• Central nervous system metastases, or significant cardiovascular disease.
• Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR tyrosine kinase inhibitors (e.g. erlotinib).
• Prior treatment with oxaliplatin for metastatic disease. Adjuvant therapy with oxaliplatin based combination for non-metastatic disease is allowed if terminated \> 6 months prior to initiation of screening and without progression during the treatment with oxaliplatin.

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• iOMEDICO AG: collaborator

Study Sites (1)

AIO-Studien-gGmbH

Berlin, State of Berlin, 10623, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Oxaliplatin; Capecitabine; Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 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

Study Officials

• Ralf Grunewald, PD Dr.

  Gemeinschaftspraxis Hämatologie / Onkologie Im Prüfling 17-19 60389 Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 3, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 4, 2013

Record last verified: 2013-03

Locations

DE (1)