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COMPLETED Phase 2

Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium

NCT00053209 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.

Interventions

  • DRUG gemcitabine hydrochloride
  • DRUG pemetrexed disodium

Study Locations (20)

Colorado

  • Aurora Presbyterian Hospital — Aurora
  • Boulder Community Hospital — Boulder
  • Penrose Cancer Center at Penrose Hospital — Colorado Springs
  • Porter Adventist Hospital — Denver
  • Presbyterian - St. Luke's Medical Center — Denver
  • St. Joseph Hospital — Denver
  • Rose Medical Center — Denver
  • CCOP - Colorado Cancer Research Program, Incorporated — Denver
  • Swedish Medical Center — Englewood
  • Sky Ridge Medical Center — Lone Tree
  • Hope Cancer Care Center at Longmont United Hospital — Longmont
  • St. Mary-Corwin Regional Medical Center — Pueblo
  • North Suburban Medical Center — Thornton

Delaware

  • Beebe Medical Center — Lewes
  • CCOP - Christiana Care Health Services — Newark
  • St. Francis Hospital — Wilmington

Florida

  • Baptist Cancer Institute - Jacksonville — Jacksonville
  • Watson Clinic, LLC — Lakeland

Connecticut

  • Yale Comprehensive Cancer Center at Yale University School of Medicine — New Haven

Georgia

  • Hematology and Oncology of Northeast Georgia — Athens

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2004-08-10
Est. Completion 2009-05
Phase Phase 2

Sponsor

Eastern Cooperative Oncology Group

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00053209

The ClinicalTrials.gov registry entry for NCT00053209 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Cooperative Oncology Group, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions — of which gemcitabine hydrochloride is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00053209 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Colorado, Delaware, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00053209 about?

NCT00053209 is a clinical study titled "Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium". RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine ...

What is the current status of trial NCT00053209?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2004-08-10. Estimated completion is 2009-05.

What conditions does trial NCT00053209 study?

This clinical trial studies the following conditions: Bladder Cancer, Urethral Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00053209?

The interventions under investigation include: gemcitabine hydrochloride (DRUG), pemetrexed disodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00053209?

This trial is sponsored by Eastern Cooperative Oncology Group, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00053209 being conducted?

This trial has 20 study locations across Colorado, Connecticut, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial