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For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy

25. september 2008 opdateret af: Pfizer

Phase II, Randomized, Double-Blind, Multicenter Trial Of Celecoxib Vs Placebo For The Prevention Of Diarrhea Associated With CPT-11/5fu/LV Chemotherapy In Patients With Previously Untreated Metastatic Colorectal Cancer

The Diarrhea Prevention with an investigational drug trial, will evaluate whether adding an investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5FU), and leucovorin (also known as LV). Preclinical data from animal models suggest that the investigational drug may offer an effective means for preventing CPT-11/5FU/LV-induced diarrhea. It is also hypothesized that the investigational drug-mediated anti-angiogenesis could induce a favorable tumor response.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

212

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Mobile, Alabama, Forenede Stater, 36685
    - Pfizer Investigational Site
- Florida
  - Ft. Lauderdale, Florida, Forenede Stater, 33308
    - Pfizer Investigational Site
  - Port St. Lucie, Florida, Forenede Stater, 34952
    - Pfizer Investigational Site
- Illinois
  - Chicago, Illinois, Forenede Stater, 60631
    - Pfizer Investigational Site
- Missouri
  - St. Joseph, Missouri, Forenede Stater, 64507
    - Pfizer Investigational Site
  - St. Louis, Missouri, Forenede Stater, 63136
    - Pfizer Investigational Site
- New York
  - Buffalo, New York, Forenede Stater, 14215
    - Pfizer Investigational Site
  - Williamsville, New York, Forenede Stater, 14221
    - Pfizer Investigational Site
- Pennsylvania
  - Altoona, Pennsylvania, Forenede Stater, 16601
    - Pfizer Investigational Site
- Washington
  - Puyallup, Washington, Forenede Stater, 98372
    - Pfizer Investigational Site
  - Yakima, Washington, Forenede Stater, 98902
    - Pfizer Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease and present or past histological documentation of adenocarcinoma of the colon or rectum.
Tumor must be measureable.
Resolution of all acute toxic effects of any prior radiotherapy or surgical procedure.
ECOG performance status 0 or 1. Age >= 18 years.
Required baseline laboratory.
Negative pregnancy test.
Willingness and ability to comply with the treatment plan.

Exclusion Criteria:

Current enrollment in another clinical trial.
Prior adjuvant therapy for colorectal cancer <= 6 months prior to randomization.
Prior systemic anticancer therapy or intra-arterial cytotoxic chemotherapy given as treatment for metastatic colorectal cancer.
Known allergy to CPT-11, 5-FU, LV, celecoxib, other COX-2 inhibitors, non-steroidal anti-inflammatory drugs (NSAIDS), salicylates, or sulfonamides.
Chronic concomitant use of full-dose aspirin, other NSAIDs or other COX-2 inhibitors for a chronic nonmalignant condition.
A requirement for chronic concomitant use of low-dose (cardioprotective) aspirin.
Chronic oral steroid use for treatment of a non-malignant condition.
Known ulceration of the gastric or duodenal mucosa <= 30 days prior to randomization.
Need for concomitant fluconazole or lithium.
Any known significant bleeding disorder.
Active inflammatory bowel disease or chronic diarrhea.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Incidence of NCI CTC grade 2-4 diarrhea during the first cycle (6 weeks) of CPT-11/5-FU/LV chemotherapy

Sekundære resultatmål

Resultatmål
Tid til behandlingssvigt (TTF)
Tid til tumorprogression (TTP)
Severity of all grades of diarrhea, overall and by cycle
Duration of diarrhea, by cycle
Diarrhea grade, by day, by cycle
Stool count, by day, by cycle
Severity of asthenia (fatigue), by week.
Asthenia will be assessed with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Duration of asthenia, by week, as measured by the FACIT-Fatigue scale
Type, frequency, severity, timing, and relatedness of all adverse events CPT-11/5-FU/LV treatment administration as characterized by median, mean, and range of doses given; dose modifications, omissions, and delays; and actual and relative dose intensity
Compliance with celecoxib use Incidence, quantity, and duration of loperamide use
Tumor response rate (overall and confirmed)using the World Health Organization [WHO] Response Evaluation Criteria in Solid Tumors [RECIST 2000]
Serum tumor marker (carcinoembryonic antigen [CEA]) response rate (as characterized by a 50% reduction from baseline)
Survival Post-study anticancer treatment
Peak plasma levels and AUC 0-24 values for CPT-11 and its major metabolites, SN-38, SN-38 glucuronide (SN-38G), and aminopentane carboxylic acid (APC)
Inflammatory cytokines which may serve as biomarkers for cancer-related outcomes Beta-glucuronidase as a potential biomarker for tumor response
Health resource utilization (collected data to be evaluated separately from this protocol)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

To obtain contact information for a study center near you, click here.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2002

Studieafslutning (Faktiske)

1. januar 2003

Datoer for studieregistrering

Først indsendt

16. maj 2002

Først indsendt, der opfyldte QC-kriterier