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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00182806

NCT00182806
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with non-small cell lung cancer (NSCLC), confirmed by a tissue or cell sample test.
  • Your cancer is either stage IIIA or IIIB and has gotten worse/progressed, OR it is stage IV and you have already tried one chemotherapy treatment that included a platinum-based drug (including treatments given after surgery).
  • Your cancer can be seen and measured (or at least detected) on a scan.
  • If your cancer has spread to the brain, you have already received treatment for it, you have no brain-related symptoms, and the cancer has also spread somewhere else outside the brain.
  • You are 18 years of age or older.
  • You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site).
  • Your doctors expect you to live for more than 12 weeks.
  • Your blood cell counts (white blood cells, neutrophils, and platelets) are at healthy enough levels (confirm with trial site).
  • Your liver is working well enough, based on blood test results (confirm with trial site).
  • Your kidneys are working well enough, based on blood test results (confirm with trial site).
  • If you are able to have children, you must be willing to use effective barrier contraception (such as condoms) during treatment and for 3 months after finishing.

Who may not be able to join:

  • You are pregnant or breastfeeding, or your pregnancy test comes back positive.
  • You have unstable chest pain (unstable angina), heart failure, or had a heart attack within the last 3 months.
  • You have a serious, life-threatening heart rhythm problem that requires ongoing treatment.
  • You have a seizure disorder that is not well controlled.
  • You have diabetes that is not well controlled.
  • You have an active infection that requires treatment with medication taken throughout your body (such as IV or oral antibiotics).
  • You have had another type of cancer in the past 5 years, except for certain skin cancers or a very early-stage cervical condition.
  • You have received chemotherapy within the last 3 weeks, or radiotherapy within the last 4 weeks.
  • You have previously been treated with a chemotherapy drug called gemcitabine.
  • You have had more than one chemotherapy treatment for your lung cancer (not counting a drug called gefitinib).
  • You are currently receiving any other chemotherapy or radiation therapy.
  • You took part in another clinical trial using an experimental treatment within the last month.
  • You are currently taking any other experimental treatments.
  • You have any other serious or unstable medical condition.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Roswell Park Cancer Institute
Registry
clinicaltrials_gov
Start date
1 September 2004
Est. completion
1 September 2007

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective response (complete, partial, and stable disease)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov