Extensive Stage Small Cell Lung CancerPhase 2NCT00020202
FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer
A Phase 2 study testing FR901228 in people with Extensive Stage Small Cell Lung Cancer and Stage IIIA Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 FR901228 in treating patients who have refractory or progressive small cell lung cancer or non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- What is being tested?
- FR901228
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Mar 2007
- 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
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically or cytologically confirmed primary extensive stage small cell or unresectable non-small cell lung cancer Must have received or refused prior platinum-based chemotherapy and exhibited refractory or progressive disease Tumor must be accessible to biopsy by bronchoscopic or percutaneous fine needle aspiration technique Measurable disease outside of irradiated field or documented progression since irradiation Extrathoracic metastases allowed No active intracranial or leptomeningeal metastases Prior surgical resection or radiotherapy for intracranial metastatic disease allowed if: No evidence of active disease on 2 MRI scans AND No requirement for anticonvulsant medications or steroids to control residual symptoms --Prior/Concurrent Therapy-- Biologic therapy: At least 30 days since prior biologic therapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy, including nitrosoureas or mitomycin, and recovered No prior FR901228 No prior doxorubicin of total dose greater than 450 mg/m2 Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 30 days since prior radiotherapy and recovered At least 4 weeks since prior radiotherapy to the lung or mediastinum Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: PT/PTT normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Ejection fraction greater than 40% No unstable angina, congestive heart failure, or uncontrolled cardiac dysrhythmia No deep vein thrombosis requiring anticoagulation Pulmonary: No pulmonary embolism within past 6 months FEV1 and DLCO greater than 30% predicted pCO2 less than 50 mm Hg on room air pO2 greater than 60 mm Hg on room air Other: HIV negative No active infections Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of FR901228 in Patients With Refractory or Progressive Small Cell or Non-Small Cell Lung Cancer
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 FR901228 in treating patients who have refractory or progressive small cell lung cancer or non-small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Determine the response of patients with refractory or progressive small cell or non-small cell lung cancer to FR901228.
II. Determine the ability of FR901228 to mediate apoptosis and target gene induction relative to tumor histology in these patients.
III. Determine the toxicity of this treatment in these patients.
PROTOCOL OUTLINE: Patients are stratified according to disease histology (small cell lung cancer vs non-small cell lung cancer).
Patients receive FR901228 IV over 4 hours on days 1 and 7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL:
A total of 18-43 patients (9-21 per arm) will be accrued for this study within 18 months.
- Conditions
- Extensive Stage Small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer
- Being tested
- FR901228
- Keywords
- adult solid tumor, body system/site cancer, cancer, extensive stage small cell lung cancer, genetic condition, lung cancer, non-small cell lung cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, small cell lung cancer, solid tumor, stage III non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, stage, non-small cell lung cancer, stage, small cell lung cancer, thorax/respiratory cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Neoplasms, Genetic Diseases, Inborn, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FR901228Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startJun 2000
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- David S. Schrump, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020202
- Sponsor's protocol ID
- CDR0000068031
- Other IDs
- NCI-00-C-0123, NCI-1053
- Status last verified
- Feb 2024
- First submitted
- 2 Mar 2007
- Last updated
- 4 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of FR901228 in Patients With Refractory or Progressive Small Cell or Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00020202
- Acronym / sponsor ID
- CDR0000068031
- Conditions
- Extensive Stage Small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer
- Keywords
- adult solid tumor, body system/site cancer, cancer, extensive stage small cell lung cancer, genetic condition, lung cancer, non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- Mar 2007 (actual)
- First posted
- 5 Mar 2007 (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 FR901228 in treating patients who have refractory or progressive small cell lung cancer or non-small cell lung cancer.
Detailed description
OBJECTIVES: I. Determine the response of patients with refractory or progressive small cell or non-small cell lung cancer to FR901228.
II. Determine the ability of FR901228 to mediate apoptosis and target gene induction relative to tumor histology in these patients.
III. Determine the toxicity of this treatment in these patients.
PROTOCOL OUTLINE: Patients are stratified according to disease histology (small cell lung cancer vs non-small cell lung cancer).
Patients receive FR901228 IV over 4 hours on days 1 and 7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL:
A total of 18-43 patients (9-21 per arm) will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| FR901228 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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.
David S. Schrump study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FR901228 in people with Extensive Stage Small Cell Lung Cancer and Stage IIIA Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 4 Mar 2024.