Lung CancerPhase 2NCT00022711
Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
A Phase 2 study testing temozolomide in people with Lung Cancer, run by Fox Chase Cancer Center at 17 sites 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 temozolomide in treating patients who have relapsed or progressive 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?
- temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 17 sitesUnited States
- Study dates
- Jan 2002to Jan 2004
- 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 relapsed or progressive small cell lung cancer
- Classical or intermediate variant OR
- Relapsed or progressive extrapulmonary small cell carcinoma of unknown origin
- Bidimensionally measurable disease
- At least 1 cm by 1 cm by physical exam or radiologic exam
- Outside prior radiation port unless clinical evidence of disease progression
- Previously radiated brain metastases allowed provided stable or improved
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT/SGPT no greater than 3 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 5 times ULN
Renal:
- Creatinine no greater than 2 mg/dL
Other:
- HIV negative
- No AIDS-related illness
- No frequent vomiting or medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction)
- No active nonmalignant systemic disease that would preclude study
- No other active invasive malignancy within the past year or concurrently requiring ongoing treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy
- No concurrent immunotherapy
- No concurrent biologic therapy
- Concurrent epoetin alfa allowed
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No more than 1 prior continuous or discontinuous chemotherapy regimen for metastatic disease
- No other concurrent chemotherapy
Endocrine therapy:
- Concurrent hormonal therapy to boost appetite allowed (e.g., corticosteroids or medroxyprogesterone)
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy to 15% or more of bone marrow
- At least 1 week since prior radiotherapy to less than 15% of bone marrow
- No prior radiotherapy to 50% or more of bone marrow
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- Recovered from prior therapy
- No other concurrent investigational drugs
- Concurrent pamidronate allowed
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026-1186
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
Kimball Medical Center
Lakewood, New Jersey, 08701
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
Central Montgomery Medical Center
Lansdale, Pennsylvania, 19446-1200
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
Community Medical Center
Toms River, New Jersey, 08755
St. Francis Medical Center
Trenton, New Jersey, 08629
About this study
Official title: A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed 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 temozolomide in treating patients who have relapsed or progressive small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of temozolomide, in terms of response rate and safety, in patients with relapsed or progressive small cell lung cancer.
- Determine the time to progression and overall survival in patients treated with this drug.
- Assess quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy).
Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter.
Patients are followed at 30 days and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- temozolomide
- Keywords
- recurrent small cell lung cancer, intermediate type small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
150 mg/m2/day Repeat cycles every 28 days following first daily dose of each cycle until toxicity or disease progression for a maximum of six months
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Experimental | Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months Receives: Drug: temozolomide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
- Primary completionJan 2004
- Study completionJan 2004
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 Fox Chase 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Corey J. Langer, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022711
- Sponsor's protocol ID
- FCCC-01020
- Other IDs
- NCI-G01-2005
- Status last verified
- Jul 2013
- First submitted
- 10 Aug 2001
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00022711
- Acronym / sponsor ID
- FCCC-01020
- Conditions
- Lung Cancer
- Keywords
- recurrent small cell lung cancer, intermediate type small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2002
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 27 Jan 2003 (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 temozolomide in treating patients who have relapsed or progressive small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of temozolomide, in terms of response rate and safety, in patients with relapsed or progressive small cell lung cancer.
- Determine the time to progression and overall survival in patients treated with this drug.
- Assess quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy).
Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter.
Patients are followed at 30 days and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temozolomide | Experimental | Drug: temozolomideTemozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months |
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 |
|---|---|---|
| temozolomide150 mg/m2/day Repeat cycles every 28 days following first daily dose of each cycle until toxicity or disease progression for a maximum of six months | Drug | Temozolomide |
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 11 Jul 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.
Corey J. Langer, MD study chair
Fox Chase Cancer Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temozolomide in people with Lung Cancer, run by Fox Chase Cancer Center at 17 sites 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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 11 Jul 2013.