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

NCT00094809 | Completed Phase 2 Results

• 1 other identifier: 20020715
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colon Cancer; Colorectal Cancer; Rectal Cancer

Keywords

Neulasta®; pegfilgrastim; Advanced; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Grade 3 or 4 Neutropenia

  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

  First 4 cycles of treatment (8 weeks)

• Grade 4 Neutropenia

  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

  First 4 cycles of treatment (8 weeks)

Secondary Outcomes (8)

• Dose Delay or Reduction Due to Neutropenia

  First 4 cycles of treatment (8 weeks)

• Dose Delay or Reduction for Any Reason

  First 4 cycles of treatment (8 weeks)

• Febrile Neutropenia

  First 4 cycles of treatment (8 weeks)

• Hospitalization Due to a Neutropenia-Related Event

  First 4 cycles of neutropenia (8 weeks)

• Progression-Free Survival

  Up to 24 months after first four cycles of treatment

Study Arms (2)

Pegfilgrastim

ACTIVE COMPARATOR

6 mg pegfilgrastim

Drug: Pegfilgrastim

Placebo

PLACEBO COMPARATOR

6 mg placebo

Drug: Placebo

Interventions

Placebo DRUG

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.

Placebo

Pegfilgrastim DRUG

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.

Pegfilgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• 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.

  PMID: 20378503 BACKGROUND

• Lyman GH, Reiner M, Morrow PK, Crawford J. The effect of filgrastim or pegfilgrastim on survival outcomes of patients with cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Jul;26(7):1452-8. doi: 10.1093/annonc/mdv174. Epub 2015 Apr 7.

  PMID: 25851633 DERIVED

Related Links

• AmgenTrials clinical trials website
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Rectal Neoplasms

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2004
• First Posted: October 26, 2004
• Study Start: February 1, 2003
• Primary Completion: May 19, 2006
• Study Completion: January 23, 2008
• Last Updated: October 17, 2018
• Results First Posted: January 6, 2011

Record last verified: 2018-09