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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

December 12, 2006
July 14, 2014
December 2006
July 2009   (final data collection date for primary outcome measure)
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 ]
To estimate the effect of Kras mutation status(wild type vs mutant) from tumor tissue on efficacy endpoints in subjects with mCRC receiving second line FOLFIRI with panitumumab after failing 1st line treatment containing fluoropyrimidine and oxaliplatin
Complete list of historical versions of study NCT00411450 on ClinicalTrials.gov Archive Site
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 ]
To evaluate the safety profile (incidence of adverse events and significant laboratory changes) of second-line FOLFIRI with panitumumab
Not Provided
Not Provided
 
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
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

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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • Cancer
  • Metastatic Cancer
  • Metastatic Colorectal Cancer
  • Oncology
  • Drug: panitumumab
    6mg/kg Q2W
  • Drug: FOLFIRI
    FOLFIRI prescription per the most current package insert(s)
Experimental: panitumumab plus FOLFIRI
Subjects receiving panitumumab plus FOLFIRI
Interventions:
  • Drug: panitumumab
  • Drug: FOLFIRI
Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Pérez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
October 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00411450
20060277
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP