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OpenTrials
Completed

NCT Number: NCT00089635

Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer

The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
  • Metastatic colorectal carcinoma
  • Eastern Cooperative Oncology Group of 0, 1 or 2
  • Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
  • Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
  • Bidimensionally measurable disease
  • Tumor expressing low to negative levels of epidermal growth factor receptor (EGFr) by immunohistochemistry
  • At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
  • Adequate hematologic, renal and hepatic function

Exclusion criteria

  • Symptomatic brain metastases requiring treatment
  • Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
  • Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted
  • Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment

Treatment and study plan

Panitumumab

Drug

Administered by intravenous infusion

Other names: ABX-EGF, Vectibix®

Primary outcomes

  1. Objective Tumor Response Through Week 16

    Time frame: From enrollment through Week 16

    Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.

  2. Duration of Response

    Time frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

    Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.

Secondary outcomes

  1. Objective Tumor Response Throughout the Study

    Time frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

    Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.

  2. Time to Initial Objective Response

    Time frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

    Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.

  3. Progression-free Survival Time

    Time frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

    Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.

  4. Time to Disease Progression

    Time frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

    Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.

  5. Time to Treatment Failure

    Time frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

    Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.

  6. Duration of Stable Disease

    Time frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

    Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.

    Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started.

  7. Overall Survival

    Time frame: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

    Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Aug 11, 2004
Registry last updated
Nov 7, 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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