CompletedPhase 2

Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

United States4 participantsStarted 2003-05

Plain-language summary

RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Locally advanced (stage IIIB) or metastatic (stage IV) disease * Inoperable disease * Relapsed or refractory disease * Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease * Measurable or evaluable disease * No symptomatic or inadequately treated brain metastases * No CNS disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL * Absolute neutrophil count greater than 1,500/mm\^3 Hepatic * AST and ALT less than 3 times upper limit of normal (ULN) * Bilirubin less than 1.5 times ULN * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Creatinine less than 1.8 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No electrocardiographic evidence of acute ischemia or active conduction system abnormalities * No poorly controlled hypertension Immunologic * No active systemic infection requiring treatment * No prior allergic reaction attributable to compounds containing boron or mannitol * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00064012

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-07

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