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Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT01732783
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : August 20, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

Condition or disease Intervention/treatment
Wild-type RAS Metastatic Colorectal Cancer Other: Panitumumab + Chemotherapy

Study Design
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Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer
Actual Study Start Date : December 10, 2012
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Metastatic Colorectal Cancer
Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy.
 Other: Panitumumab + Chemotherapy
Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer.
Other Name: Vectibix®


Outcome Measures
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Primary Outcome Measures :
  1. Total Number of Panitumumab Infusions [ Time Frame: 12 months ]
  2. Cumulative Dose of Panitumumab [ Time Frame: 12 months ]
  3. Maximum Dose of Panitumumab [ Time Frame: 12 months ]
  4. Duration of Panitumumab Exposure [ Time Frame: 12 months ]
    Duration of exposure is the time from the first to the last panitumumab infusion

  5. Mean Interval Between Panitumumab Infusions [ Time Frame: 12 months ]
  6. Percentage of Participants With at Least One Panitumumab Dose Reduction [ Time Frame: 12 months ]
  7. Percentage of Participants With at Least One Panitumumab Dose Delay [ Time Frame: 12 months ]
  8. Reasons for Discontinuation of Panitumumab [ Time Frame: 12 months ]
  9. Duration of Exposure of All Concomitant Chemotherapy [ Time Frame: 12 months ]
    Duration of exposure is the time from the first date to the last date of chemotherapy administration.

  10. Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction [ Time Frame: 12 months ]
  11. Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of Participants With at Least One Hospitalization [ Time Frame: 12 months ]
  2. Types of Hospital Visit [ Time Frame: 12 months ]
    Participants may have had more than one type of hospital visit.

  3. Duration of Hospital Stay [ Time Frame: 12 months ]
  4. Reasons for Hospitalization [ Time Frame: 12 months ]
    Participants may have had more than one hospital visit and/or reason for a hospital visit.

  5. Percentage of Participants With an Overall Response [ Time Frame: 12 months ]
    Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).

  6. Number of Participants With Resectability [ Time Frame: 12 months ]
    Resectability denotes whether a participant became resectable during the study.

  7. Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation [ Time Frame: 12 months ]
  8. Type of Post-Panitumumab Anti-cancer Treatment [ Time Frame: 12 months ]
    Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All treatment centres (inpatient and outpatient) with a focus on treating patients with mCRC. Centres will be selected to represent academic, oncology and specialist settings and to provide geographical diversity in France and Germany.
Criteria

Inclusion Criteria

  • Subject is ≥ 18 years of age at date of enrolment
  • Histologically or cytologically confirmed carcinoma of colon or rectum
  • Subject with metastatic carcinoma of colon or rectum
  • Confirmed wild-type RAS status of tumour
  • Subjects whose care will be managed primarily by the enrolling physician and/ or all records will be available
  • Tumour assessment (ie, computed tomography [CT]/magnetic resonance imaging [MRI]) within 12 weeks (84 days) prior to first Vectibix® infusion.
  • Subjects treated with at least one infusion of Vectibix® in combination with chemotherapy a maximum of 84 days before entering study: first-line in combination with FOLFOX (folinic acid, leucovorin, fluorouracil [5FU], oxaliplatin) or second-line in combination with FOLFIRI (folinic acid, leucovorin, 5FU, irinotecan) in subjects who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for treatment of wild-type RAS mCRC per approved prescribing information
  • Subject or subject's legally acceptable representative has provided informed consent (for countries where required per local regulations)
  • Subjects treated with Vectibix® in accordance with the current version of the Summary of Product Characteristics (SmPC)

Exclusion Criteria

  • Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency for any indication
  • Ongoing or planned concurrent participation in any clinical study where the dosing of Vectibix® is determined by the protocol (participation in clinical trials on an approved drug and observational trials are permitted but these cannot mandate how mCRC should be treated)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732783


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01732783    
Other Study ID Numbers: 20120100
First Posted: November 26, 2012    Key Record Dates
Results First Posted: August 20, 2018
Last Update Posted: October 18, 2018
Last Verified: September 2018
Keywords provided by Amgen:
Wild-type RAS
Metastatic Colorectal Cancer
Vectibix
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents