Lung CancerPhase 2NCT00021008
ZD0473 in Treating Patients With Progressive or Relapsed Non-Small Lung Cancer
A Phase 2 study testing picoplatin in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ZD0473 in treating patients who have progressive or relapsed non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- picoplatin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Progressive or relapsed disease after first-line platinum-based chemotherapy Measurable disease No intracerebral metastases (unless asymptomatic, no corticosteroids required, and diagnostic imaging demonstrates no peritumoral edema or progression)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.25 times the upper limit of normal (ULN) ALT or AST less than 2.5 times ULN (5 times ULN if liver metastases present) No hepatic impairment No risk of hepatitis B transmission Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No currently unstable or uncompensated cardiac conditions Pulmonary: No currently unstable or uncompensated respiratory conditions Other: No risk of HIV transmission No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No other severe or uncontrolled systemic disease No infectious condition No significant clinical disorder that would preclude study Body surface area at least 1.2 m2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception for 3 months before, during, and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: No prior extensive radiotherapy to 30% or more of bone marrow (e.g., whole of pelvis or half of spine) Surgery: Recovered from prior surgery Other: At least 2 weeks since prior systemic anticancer therapy and recovered
About this study
Official title: A Phase II Open, Multicenter Trial to Assess the Activity and Tolerability of ZD0473 Given Intravenously as Second-line Therapy to Patients With Non-Small Lung Cancer Who Have Failed One Prior Platinum Based Chemotherapy Regimen
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ZD0473 in treating patients who have progressive or relapsed non-small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Determine the anti-tumor effect of ZD0473 in patients with progressive or relapsed non-small cell lung cancer who have failed first-line platinum-based chemotherapy. II. Assess the safety and tolerability of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the efficacy of this drug, in terms of time to death, time to disease progression, disease control, and duration of response, in these patients. V. Assess the therapy outcome index, in terms of disease-related symptom relief, of these patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to time to relapse or progression after completion of first-line platinum-based chemotherapy (12 weeks or less vs more than 12 weeks). Patients receive ZD0473 IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the beginning of each course, and then every 6 weeks for 1 year after completion of study. Patients are followed at 30 days after study completion and every 6 weeks for 1 year.
PROJECTED ACCRUAL: A total of 32-73 patients (23-56 per stratum 1 and 9-17 per stratum 2) will be accrued for this study within approximately 9 months.
- Conditions
- Lung Cancer
- Being tested
- picoplatin
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
picoplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert A. Figlin, MD, FACP, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021008
- Sponsor's protocol ID
- CDR0000068738
- Other IDs
- UCLA-000307201A, ZENECA-0473IL/0003, NCI-G01-1974
- Status last verified
- Sep 2001
- First submitted
- 11 Jul 2001
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open, Multicenter Trial to Assess the Activity and Tolerability of ZD0473 Given Intravenously as Second-line Therapy to Patients With Non-Small Lung Cancer Who Have Failed One Prior Platinum Based Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT00021008
- Acronym / sponsor ID
- CDR0000068738
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 13 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ZD0473 in treating patients who have progressive or relapsed non-small cell lung cancer.
Detailed description
OBJECTIVES: I. Determine the anti-tumor effect of ZD0473 in patients with progressive or relapsed non-small cell lung cancer who have failed first-line platinum-based chemotherapy. II. Assess the safety and tolerability of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the efficacy of this drug, in terms of time to death, time to disease progression, disease control, and duration of response, in these patients. V. Assess the therapy outcome index, in terms of disease-related symptom relief, of these patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to time to relapse or progression after completion of first-line platinum-based chemotherapy (12 weeks or less vs more than 12 weeks). Patients receive ZD0473 IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the beginning of each course, and then every 6 weeks for 1 year after completion of study. Patients are followed at 30 days after study completion and every 6 weeks for 1 year.
PROJECTED ACCRUAL: A total of 32-73 patients (23-56 per stratum 1 and 9-17 per stratum 2) will be accrued for this study within approximately 9 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| picoplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A. Figlin, MD, FACP study chair
Jonsson Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing picoplatin in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.