Breast CancerPhase 2NCT00194766
Continuous Temozolomide in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer
A Phase 2 study testing Temozolomide in people with Breast Cancer and Soft Tissue Sarcoma, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Soft Tissue Sarcoma
- What is being tested?
- Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Dec 2006
- 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
Who may be able to join
- Patients must have either:
- Stage IV, microscopically-confirmed carcinoma of the breast with:
- Relapse or progression while receiving, or within 12 months of having received, an anthracycline-containing (doxorubicin or mitoxantrone) or taxane-containing (paclitaxel or docetaxel) regimen as either adjuvant treatment or therapy for advanced breast cancer, or
- Treatment to a maximum dose of anthracycline (e.g., greater than 450 mg/m2 of doxorubicin), or
- A dose-limiting toxicity from a taxane, or
- An ECOG performance status of 2.
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- OR -
- Unresectable or metastatic, microscopically-confirmed soft tissue sarcoma, that is not amenable to treatment with Adriamycin or Ifosfamide due to:
- Poor cardiac reserve, or
- Poor performance status (ECOG performance status = 2) or
- Having failed treatment with Adriamycin or reached dose-limiting toxicity from chemotherapy.
- Patients must have histologic slides and/or blocks must be available for review.
- Patients must have measurable (bidimensionally) or evaluable disease.
- Patients must be 18 years old or older.
- Patients must have Karnofsky Performance Status greater than 70% (ECOG less than 2) at screen and on the first day of treatment.
- Patients must have a life expectancy more than 16 weeks.
- Patients must be informed consent must be obtained prior to enrollment.
- Patients must be more than 2 weeks from prior surgery; more than 3 weeks from radiation therapy to the pelvis, spine or long bones; more than 3 weeks from prior chemotherapy (more than 6 weeks for mitomycin C or nitrosureas), or more than 2 weeks from prior hormonal therapy.
Who cannot join
- Granulocytes less than 1,500/mm3.
- Platelet count less than 100,000/mm3.
- Hemoglobin less than 10 gm/dl.
- Creatinine greater than 2.0 mg/dl.
- Total bilirubin greater than ULN (institutional upper limit of normal).
- Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases (i.e. patients whose disease is beyond control).
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- Medically unstable (i.e. with uncontrolled disease); diagnosis of other systemic cancer.
- Pregnancy or lactation; failure to employ adequate contraception.
- Uncontrolled CNS disease.
- Greater than 30% marrow previously irradiated.
- Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: Continuous Temozolomide (SCH 52365) in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer, Phase II
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma.
Read the detailed description
Because repeated dosing of temozolomide correlates with an improved response, which may be due to progressive depletion of the enzyme AT, our hope is that a daily oral schedule will be the most active schedule of this agent. In phase I studies doses below 85 mg/m2/day continuously have been well-tolerated. We plan to begin dosing at 75 mg/m2/day for 6 weeks out of an 8 week cycle and to escalate to 85 and 100 mg/m2/day in patients who have no grade 3/4 toxicity.
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma. To do this we will assess the response rate, time to progression, and survival in patients with advanced breast cancer or soft tissue sarcoma who are treated with temozolomide.
- Conditions
- Breast Cancer, Soft Tissue Sarcoma
- Being tested
- Temozolomide
- Keywords
- Breast cancer, Soft tissue sarcoma
- Medical subject headings
- Breast Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment. Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: <= 78 months
Secondary outcomes (3)
Time to disease progression
Measured: <= 78 months
Survival
Measured: <= 78 months
To determine the toxicity of the regimen.
Measured: <= 78 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2000
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- James Butrynski, M.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194766
- Sponsor's protocol ID
- 99-1283-A
- Status last verified
- Nov 2007
- First submitted
- 14 Sep 2005
- Last updated
- 14 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Temozolomide (SCH 52365) in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer, Phase II
- ClinicalTrials.gov ID
- NCT00194766
- Acronym / sponsor ID
- 99-1283-A
- Conditions
- Breast Cancer, Soft Tissue Sarcoma
- Keywords
- Breast cancer, Soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Jul 2000
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Sep 2005 (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.
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma.
Detailed description
Because repeated dosing of temozolomide correlates with an improved response, which may be due to progressive depletion of the enzyme AT, our hope is that a daily oral schedule will be the most active schedule of this agent. In phase I studies doses below 85 mg/m2/day continuously have been well-tolerated. We plan to begin dosing at 75 mg/m2/day for 6 weeks out of an 8 week cycle and to escalate to 85 and 100 mg/m2/day in patients who have no grade 3/4 toxicity.
The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma. To do this we will assess the response rate, time to progression, and survival in patients with advanced breast cancer or soft tissue sarcoma who are treated with temozolomide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TemozolomideTemozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Stage IV, microscopically-confirmed carcinoma of the breast with:
- Unresectable or metastatic, microscopically-confirmed soft tissue sarcoma, that is not amenable to treatment with Adriamycin or Ifosfamide due to:
- Patients must have histologic slides and/or blocks must be available for review.
- Patients must have measurable (bidimensionally) or evaluable disease.
- Patients must be 18 years old or older.
Key exclusion criteria (11 listed)
- Granulocytes less than 1,500/mm3.
- Platelet count less than 100,000/mm3.
- Hemoglobin less than 10 gm/dl.
- Creatinine greater than 2.0 mg/dl.
- Total bilirubin greater than ULN (institutional upper limit of normal).
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 |
|---|---|---|
| TemozolomideTemozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment. | Drug | 1 |
Primary outcome
Response rate
Time frame: <= 78 months
3 secondary outcomes
Time to disease progression
Time frame: <= 78 months
Survival
Time frame: <= 78 months
To determine the toxicity of the regimen.
Time frame: <= 78 months
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 14 Nov 2007.
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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.
James Butrynski, M.D. principal investigator
University of Washington
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 Temozolomide in people with Breast Cancer and Soft Tissue Sarcoma, run by University of Washington 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?
The sponsor lists 18 inclusion and 11 exclusion criteria. 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 14 Nov 2007. 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.
What does the primary outcome measure?
Response rate (time frame: <= 78 months). It is what the study was designed to measure, not a finding.
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 14 Nov 2007.