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COMPLETED Phase 2

Pemetrexed Disodium With or Without Sorafenib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00454194 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Pemetrexed disodium and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying pemetrexed disodium and sorafenib to see how well they work compared with pemetrexed disodium alone as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Conditions Studied

Interventions

  • DRUG pemetrexed disodium
  • DRUG sorafenib tosylate

Study Locations (20)

Colorado

  • Aurora Presbyterian Hospital — Aurora
  • Boulder Community Hospital — Boulder
  • Penrose Cancer Center at Penrose Hospital — Colorado Springs
  • St. Anthony Central Hospital — Denver
  • Porter Adventist Hospital — Denver
  • Presbyterian - St. Luke's Medical Center — Denver
  • St. Joseph Hospital — Denver
  • Rose Medical Center — Denver
  • CCOP - Colorado Cancer Research Program — Denver
  • Swedish Medical Center — Englewood
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction
  • North Colorado Medical Center — Greeley
  • Sky Ridge Medical Center — Lone Tree
  • Hope Cancer Care Center at Longmont United Hospital — Longmont
  • McKee Medical Center — Loveland
  • St. Mary - Corwin Regional Medical Center — Pueblo
  • North Suburban Medical Center — Thornton
  • Exempla Lutheran Medical Center — Wheat Ridge

Arizona

  • Mayo Clinic Scottsdale — Scottsdale

Florida

  • Mayo Clinic - Jacksonville — Jacksonville

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2007-09
Est. Completion 2013-05
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00454194

The ClinicalTrials.gov registry entry for NCT00454194 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 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which pemetrexed disodium 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: NCT00454194 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Colorado, Arizona, 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 NCT00454194 about?

NCT00454194 is a clinical study titled "Pemetrexed Disodium With or Without Sorafenib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer". RATIONALE: Pemetrexed disodium and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib may kill more tumor cells....

What is the current status of trial NCT00454194?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2007-09. Estimated completion is 2013-05.

What conditions does trial NCT00454194 study?

This clinical trial studies the following conditions: Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00454194?

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

Who is sponsoring clinical trial NCT00454194?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00454194 being conducted?

This trial has 20 study locations across Arizona, Colorado, Florida. 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