Colon CancerPhase 2NCT00094809

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

A Phase 2 study testing Pegfilgrastim in people with Colon Cancer and Colorectal Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colon Cancer, Colorectal Cancer, Rectal Cancer
What is being tested?: Pegfilgrastim
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 252 participants
Where: No sites listed yet
Study dates: 1 Feb 2003to 23 Jan 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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.

Who cannot join

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.

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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.

About this study

Official title: 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

Conditions: Colon Cancer, Colorectal Cancer, Rectal Cancer
Being tested: Placebo, Pegfilgrastim
Keywords: Neulasta®, pegfilgrastim, Advanced, Chemotherapy
Medical subject headings: Colonic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
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.
PegfilgrastimDrug
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.

Study groups in NCT00094809
Study group	Role	What they receive
Pegfilgrastim	Active comparator	6 mg pegfilgrastim Receives: Drug: Pegfilgrastim
Placebo	Placebo comparator	6 mg placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: First 4 cycles of treatment (8 weeks)

Secondary outcomes (8)

Dose Delay or Reduction Due to Neutropenia
Dose delay or reduction in chemotherapy doses due to neutropenia
Measured: First 4 cycles of treatment (8 weeks)
Dose Delay or Reduction for Any Reason
Dose delay or reduction in chemotherapy dose during the first 4 cycles for any reason
Measured: First 4 cycles of treatment (8 weeks)
Febrile Neutropenia
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.
Measured: First 4 cycles of treatment (8 weeks)
Hospitalization Due to a Neutropenia-Related Event
Hospitalization because of a neutropenia-related event during the first 4 cycles of treatment
Measured: First 4 cycles of neutropenia (8 weeks)
Progression-Free Survival
Kaplan-Meier estimate of the median time to disease progression or death
Measured: Up to 24 months after first four cycles of treatment
Objective Tumor Response
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.
Measured: First 4 cycles of treatment (8 weeks)
Survival
Death from any cause through the end of the follow-up period
Measured: Up to 24 months after first four cycles of treatment
Antibiotic Use Due to Febrile Neutropenia
Antibiotic use during any of the first 4 cycles of treatment due to febrile neutropenia.
Measured: First 4 cycles of treatment (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 200323 Jan 2008

First posted26 Oct 2004 (estimated)
Study start1 Feb 2003
Primary completion19 May 2006
Study completion23 Jan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Colon CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00094809
Sponsor's protocol ID: 20020715
Status last verified: Sep 2018
First submitted: 26 Oct 2004
Last updated: 17 Oct 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 20378503
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.
PubMed 25851633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Recruiting
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Not yet recruitingPhase 1
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All Colon Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00094809
Acronym / sponsor ID: 20020715
Conditions: Colon Cancer, Colorectal Cancer, Rectal Cancer
Keywords: Neulasta®, pegfilgrastim, Advanced, Chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 1 Feb 2003 (actual)
Primary completion: 19 May 2006 (actual)
Study completion: 23 Jan 2008 (actual)
First posted: 26 Oct 2004 (estimated)
Results: Posted 6 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pegfilgrastim	Active comparator	Drug: Pegfilgrastim6 mg pegfilgrastim
Placebo	Placebo comparator	Drug: Placebo6 mg placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboSubjects 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	Placebo
PegfilgrastimSubjects 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.	Drug	Pegfilgrastim

Primary outcome

Grade 3 or 4 Neutropenia
Time frame: First 4 cycles of treatment (8 weeks)
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)
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

8 secondary outcomes

Dose Delay or Reduction Due to Neutropenia
Time frame: First 4 cycles of treatment (8 weeks)
Dose Delay or Reduction for Any Reason
Time frame: First 4 cycles of treatment (8 weeks)
Febrile Neutropenia
Time frame: First 4 cycles of treatment (8 weeks)
Hospitalization Due to a Neutropenia-Related Event
Time frame: First 4 cycles of neutropenia (8 weeks)
Progression-Free Survival
Time frame: Up to 24 months after first four cycles of treatment
Objective Tumor Response
Time frame: First 4 cycles of treatment (8 weeks)
Survival
Time frame: Up to 24 months after first four cycles of treatment
Antibiotic Use Due to Febrile Neutropenia
Time frame: First 4 cycles of treatment (8 weeks)

Results and safety

Results posted to the registry on 6 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pegfilgrastim (Neulasta)	126	74
Placebo	126	61

Primary outcome: Grade 3 or 4 Neutropenia

Time frame: First 4 cycles of treatment (8 weeks). Number. Unit: Participants

Measure	Pegfilgrastim (Neulasta) n = 123	Placebo n = 118
Value	16	51

Pegfilgrastim (Neulasta) vs Placebo: Odds Ratio (OR): 0.19 (95% CI 0.10 to 0.37), p <0.0001, Mantel Haenszel

Population analysed: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

Primary outcome: Grade 4 Neutropenia

Time frame: First 4 cycles of treatment (8 weeks). Number. Unit: Participants

Measure	Pegfilgrastim (Neulasta) n = 123	Placebo n = 118
Value	13	17

Pegfilgrastim (Neulasta) vs Placebo: Odds Ratio (OR): 0.71 (95% CI 0.32 to 1.53), p = 0.3792, Mantel Haenszel

Population analysed: Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: During treatment period and including 30 days after last dose of IP. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	36 of 117 (30.8%)	108 of 117 (92.3%)	Not reported
Pegfilgrastim	44 of 124 (35.5%)	112 of 124 (90.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20378503Hecht 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.
Derived from this study: PubMed 25851633Lyman 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.
FDA-approved Drug LabelingLink provided by the sponsor.

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Active, not recruitingObservational study
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Recruiting
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Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegfilgrastim in people with Colon Cancer and Colorectal Cancer, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grade 3 or 4 Neutropenia (time frame: First 4 cycles of treatment (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094809, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.