Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim in Subjects With Advanced or Metastatic Colon Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00094809
First received: October 26, 2004
Last updated: May 10, 2013
Last verified: May 2013

October 26, 2004
May 10, 2013
February 2003
July 2008   (final data collection date for primary outcome measure)
  • Grade 3 or 4 Neutropenia [ Time Frame: First 4 cycles of treatment (8 weeks) ] [ Designated as safety issue: No ]
    Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) < 1 x 10^9/L, in any of the first four cycles of treatment
  • Grade 4 Neutropenia [ Time Frame: First 4 cycles of treatment (8 weeks) ] [ Designated as safety issue: No ]
    Grade 4 neutropenia, defined as an absolute neutrophil count (ANC) <0.5 x 10^9/L, in any of the first four cycles of treatment
Not Provided
Complete list of historical versions of study NCT00094809 on ClinicalTrials.gov Archive Site
  • Dose Delay or Reduction Due to Neutropenia [ Time Frame: First 4 cycles of treatment (8 weeks) ] [ Designated as safety issue: No ]
    Dose delay or reduction in chemotherapy doses due to neutropenia
  • Dose Delay or Reduction for Any Reason [ Time Frame: First 4 cycles of treatment (8 weeks) ] [ Designated as safety issue: No ]
    Dose delay or reduction in chemotherapy dose during the first 4 cycles for any reason
  • Febrile Neutropenia [ Time Frame: First 4 cycles of treatment (8 weeks) ] [ Designated as safety issue: No ]
    Febrile neutropenia, Defined as a temperature ≥ 38.2 °C on a given day, with an ANC < 1.0 x 10^9/L recorded on the same day or the next day, during any of the first 4 cycles of treatment.
  • Hospitalization Due to a Neutropenia-Related Event [ Time Frame: First 4 cycles of neutropenia (8 weeks) ] [ Designated as safety issue: No ]
    Hospitalization because of a neutropenia-related event during the first 4 cycles of treatment
  • Progression-Free Survival [ Time Frame: Up to 24 months after first four cycles of treatment ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the median time to disease progression or death
  • Objective Tumor Response [ Time Frame: First 4 cycles of treatment (8 weeks) ] [ Designated as safety issue: No ]
    Objective tumor response (complete or partial) at the end of treatment, defined as a reduction of at least 50% in the area of all measurable lesions (partial response) or disappearance of all measurable or evaluable disease without the development of new lesions (complete response) on computed tomographic (CT) or other scanning.
  • Survival [ Time Frame: Up to 24 months after first four cycles of treatment ] [ Designated as safety issue: No ]
    Death from any cause through the end of the follow-up period
  • Antibiotic Use Due to Febrile Neutropenia [ Time Frame: First 4 cycles of treatment (8 weeks) ] [ Designated as safety issue: No ]
    Antibiotic use during any of the first 4 cycles of treatment due to febrile neutropenia.
Not Provided
Not Provided
Not Provided
 
Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim in Subjects With Advanced or Metastatic Colon Cancer
Chemotherapy Administered Every 2 Weeks With or Without a Single Injection of Pegfilgrastim as First or Second-Line Treatment in Subjects With Locally Advanced or Metastatic Colon Cancer

The purpose of this research study is to evaluate the safety and effectiveness of pegfilgrastim in reducing grade 3/4 neutropenia when given after one of three chemotherapy regimens (FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal cancer. This study is considered to be "investigational" because the time between receiving pegfilgrastim and the next cycle of chemotherapy is only 11 days.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • Drug: Placebo
    Subjects randomized to placebo will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.
  • Drug: Pegfilgrastim
    Subjects randomized to pegfilgrastim will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.
  • Active Comparator: Pegfilgrastim
    6 mg pegfilgrastim
    Intervention: Drug: Pegfilgrastim
  • Placebo Comparator: Placebo
    6 mg placebo
    Intervention: Drug: Placebo
Hecht JR, Pillai M, Gollard R, Heim W, Swan F, Patel R, Dreiling L, Mo M, Malik I. A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer. 2010 Apr;9(2):95-101. doi: 10.3816/CCC.2010.n.013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Locally advanced or metastatic colorectal adenocarcinoma not curable by surgery or amenable to radiation therapy with curative intent.
  • Histologically or cytologically documented locally advanced or metastatic colorectal cancer. The site of the primary lesion must be or has been confirmed endoscopically, radiologically, or surgically to be or has been in the large bowel.
  • Measurable or evaluable disease.
  • ECOG performance status 0, 1 or 2
  • Life expectancy ≥ 12 weeks
  • All of the following: (1) ≥ 4 weeks must have elapsed from the time of major surgery and subjects must have recovered from the effects (e.g., laparotomy); (2) ≥ 2 weeks must have elapsed from the time of minor surgery and subjects must have recovered from the operation (insertion of a vascular access device is not considered major or minor surgery); (3) ≥ 4 weeks must have elapsed from the time of major radiotherapy (e.g., chest or bone palliative radiation therapy).
  • Subjects may have received prior adjuvant therapy and one prior chemotherapy regimen for metastatic disease providing 30 days has elapsed from last chemotherapy dose.
  • Subject must have recovered from prior chemotherapy complications and in the opinion of the investigator, the subjects current status does not place the subject at risk for entry into the trial.
  • Subjects with prior exposure to both oxaliplatin and irinotecan will not be eligible to participate in this study. However, if subject received prior therapy with oxaliplatin, they will be eligible to receive the FOLFIRI regimen. If subject received prior therapy with irinotecan, they will be eligible to receive the FOLFOX regimen.
  • Age ≥ 18 years
  • Absolute neutrophil count ≥ 1.5 x 109/L
  • Platelet count ≥100 x 109/L
  • Hemoglobin ≥ 9.0 g/dL (subjects may be receive a red blood cell transfusion to achieve this requirement)
  • Creatinine ≤ 1.5 x UNL
  • Total bilirubin ≤ 1.5 mg/dL (≤ 25.65 μmol/L), regardless of whether subjects have liver involvement secondary to tumor
  • Aspartate aminotransferase ≤ 5 x UNL
  • Alkaline phosphatase ≤ 5 x UNL
  • Informed consent to participate on the study.

Exclusion Criteria:

  • Standard chemoradiation as adjuvant treatment for colorectal cancer will be allowed, but prior radiotherapy to >15% of bone marrow or outside of standard adjuvant colorectal cancer chemoradiation is not allowed.
  • Known central nervous system metastases or carcinomatous meningitis.
  • Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of >3 loose stools daily in subjects without a colostomy or ileostomy. Subjects with a colostomy or ileostomy may be entered at the Investigator's discretion.
  • Pleural effusion or ascites, which cause respiratory compromise (≥Grade 2 dyspnea).
  • Concurrent use of other investigational agents.
  • No active infection requiring the start of systemic (intravenous or oral) anti-infective (antibiotic, antifungal, antiviral) within 72 hours of the administration of the first cycle of study chemotherapy.
  • Symptomatic sensory peripheral neuropathy.
  • The following conditions: Uncontrolled high blood pressure; unstable angina; symptomatic congestive heart failure; myocardial infarction ≤ 6 months prior to randomization; serious uncontrolled cardiac arrhythmia; New York Heart Association classification III or IV.
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease-free for at least five years.
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
  • Medical or psychiatric conditions which, in the opinion of the Investigator, make participation in an investigational trial of this nature a poor risk.
  • Known sensitivity to E. coli derived products (e.g., Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A) or known sensitivity to any of the products to be administered during dosing.
  • Subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s).
  • Subject of child-bearing potential is evidently pregnant (e.g., positive HCG test) or is breast feeding.
  • Subject is not using adequate contraceptive precautions.
  • Subject will not be available for follow-up assessment.
  • Concerns for subject's compliance with the protocol procedures.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00094809
20020715
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2013

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