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NCT00326599 · ClinicalTrials.gov registry record · Phase 2

Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 2
Development phase
101
Enrollment target

NCT00326599: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT00326599 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00326599, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 2
Development phase
101 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving gemcitabine and carboplatin together with AZD2171 may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and carboplatin together with AZD2171 works compared to giving gemcitabine and carboplatin without AZD2171 as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Primary Outcome

A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions

Interventions

  • DRUG carboplatin
  • DRUG gemcitabine hydrochloride
  • DRUG cediranib maleate

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2007-06
Est. Completion 2010-02
Phase Phase 2

What the finished NCT00326599 record still lists

NCT00326599 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).

The record links to 0 conditions, and to 3 interventions - of which carboplatin is the first listed.

NCT00326599 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00326599 about?

NCT00326599 is a clinical study titled "Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer". RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and b...

What is the current status of trial NCT00326599?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2007-06. Estimated completion is 2010-02.

What interventions are being tested in trial NCT00326599?

The interventions under investigation include: carboplatin (DRUG), gemcitabine hydrochloride (DRUG), cediranib maleate (DRUG).

Who is sponsoring clinical trial NCT00326599?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00326599's enrollment target sits among peer trials

101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00326599, the US trial registry maintained by the National Library of Medicine. NCT00326599 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.