Breast CancerPhase 2NCT00005873
Nitrocamptothecin in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
A Phase 2 study testing rubitecan in people with Breast Cancer, run by Astex Pharmaceuticals, Inc. 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 nitrocamptothecin in treating patients who have locally recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- rubitecan
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally recurrent or metastatic breast cancer not amenable to surgery or radiotherapy Measurable or evaluable disease No prior radiotherapy to only target lesion Disease progression after no more than 2 prior chemotherapy treatments for metastatic disease No active CNS metastasis Prior CNS metastasis allowed with no evidence of active disease Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Hemoglobin greater than 9.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be able to have daily fluid intake of at least 3 liters No concurrent active infection No other prior malignancy in past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan, topotecan, or other camptothecin analogues At least 3 weeks since prior chemotherapy Endocrine therapy: No concurrent corticosteroids to control CNS disease Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Relapsed Metastatic Breast 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 nitrocamptothecin in treating patients who have locally recurrent or metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Assess the toxicity and efficacy of nitrocamptothecin in patients with locally recurrent or metastatic breast cancer. II. Determine the duration of response and time to treatment failure in these patients with this treatment regimen. III. Correlate serum levels of nitrocamptothecin and its lactone metabolite with response and toxicity in these patients. IV. Correlate topoisomerase I and II levels with toxicity and response in these patients.
OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for 8 weeks. Patients achieving complete or partial response or stable disease continue therapy in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 8-18 months.
- Conditions
- Breast Cancer
- Being tested
- rubitecan
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rubitecanDrug
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)
- Study startSep 1999
- Study completionApr 2004
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.
- 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
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Show-Li Sun, MD, Study chair, Astex Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005873
- Sponsor's protocol ID
- CDR0000067909
- Other IDs
- SUPERGEN-RFS2000-17, IUMC-9906-11
- Status last verified
- Sep 2001
- First submitted
- 2 Jun 2000
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Relapsed Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00005873
- Acronym / sponsor ID
- CDR0000067909
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 1999
- Study completion
- Apr 2004 (actual)
- 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 nitrocamptothecin in treating patients who have locally recurrent or metastatic breast cancer.
Detailed description
OBJECTIVES: I. Assess the toxicity and efficacy of nitrocamptothecin in patients with locally recurrent or metastatic breast cancer. II. Determine the duration of response and time to treatment failure in these patients with this treatment regimen. III. Correlate serum levels of nitrocamptothecin and its lactone metabolite with response and toxicity in these patients. IV. Correlate topoisomerase I and II levels with toxicity and response in these patients.
OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for 8 weeks. Patients achieving complete or partial response or stable disease continue therapy in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 8-18 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| rubitecan | 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 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.
Show-Li Sun, MD study chair
Astex Pharmaceuticals, Inc.
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 rubitecan in people with Breast Cancer, run by Astex Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. 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 Dec 2013.