Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00411450
First received: December 12, 2006
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This is a phase 2, multi center, open label, single arm, clinical trial to be conducted in the United States. Subjects with metastatic colorectal cancer who failed (due to disease progression or toxicity) first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab will be enrolled at approximately 60 to 80 centers.


Condition Intervention Phase
Colon Cancer
Colorectal Cancer
Rectal Cancer
Cancer
Metastatic Cancer
Metastatic Colorectal Cancer
Oncology
Drug: panitumumab
Drug: FOLFIRI
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Objective response rate at weeks 17 and 25, and best response rate; progressions-free survival at weeks 17 and 25; progression free survival time; disease control; duration of objective response; overall survival [ Time Frame: After disease progression, all subjects will be followed every 12 weeks + or - 2 weeks from the safety visit until the end of study (approximately 52 weeks after the last subject is enrolled). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence and severity of AEs, including AEs of interest for panitumumab; changes in selected laboratory values: Mg, potassium, calcium, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, ANC, Hgb and platelet count. [ Time Frame: After disease progression, all subjects will be followed every 12 weeks + or - 2 weeks from the safety visit until the end of study (approximately 52 weeks after the last subject is enrolled). ] [ Designated as safety issue: Yes ]

Enrollment: 116
Study Start Date: December 2006
Study Completion Date: October 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: panitumumab plus FOLFIRI
Subjects receiving panitumumab plus FOLFIRI
Drug: panitumumab
6mg/kg Q2W
Drug: FOLFIRI
FOLFIRI prescription per the most current package insert(s)

Detailed Description:

This is a Multi-center, Open-label, Single-arm Trial Evaluating Panitumumab in Combination with FOLFIRI Therapy Following First-line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer Study Phase: 2 Indication: Second-line metastatic colorectal cancer (mCRC) Primary Objective: To estimate the effect of Kras mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in subjects with mCRC receiving second-line FOLFIRI with panitumumab after failing first-line treatment containing fluoropyrimidine and oxaliplatin-based chemotherapy with bevacizumab Secondary Objective(s): To evaluate the safety profile (incidence of adverse events and significant laboratory changes) of second-line FOLFIRI with panitumumab Exploratory Objective(s): To investigate the incidence of potential biomarkers based on tumor cells and their effect(s) on selected safety and efficacy endpoints

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of metastatic adenocarcinoma of the colon or rectum
  • Available paraffin-embedded tumor tissue
  • Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
  • Measurable disease
  • Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

  • Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
  • Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
  • Prior irinotecan therapy. anti EGFr therapy, or vaccine for the treatment of mCRC
  • CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
  • Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
  • Clinically significant cardiovascular disease
  • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
  • Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
  • Any significant bleeding ≤6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
  • Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
  • Any co morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
  • Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411450

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

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00411450     History of Changes
Other Study ID Numbers: 20060277
Study First Received: December 12, 2006
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
k-ras
biomarker
colorectal
colon
rectal
FOLFOX
FOLFIRI

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014