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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT00022711
Study groupRoleWhat they receive
TemozolomideExperimentalTemozolomide 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.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2002
  3. Primary completionJan 2004
  4. Study completionJan 2004

Resources

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)
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

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.

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