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OpenTrials
Completed

NCT Number: NCT01732783

Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Panitumumab + Chemotherapy

Other

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 names: Vectibix®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2012
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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