Gastrointestinal Stromal TumorPhase 2NCT00005874
Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas
A Phase 2 study testing rubitecan in people with Gastrointestinal Stromal Tumor and Sarcoma, 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 advanced or metastatic soft tissue sarcomas. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Stromal Tumor, Sarcoma, Small Intestine Cancer
- What is being tested?
- rubitecan
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 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 confirmed locally advanced or metastatic inoperable soft tissue sarcoma Measurable or evaluable disease that has not been irradiated Must have received, refused, or be not eligible for doxorubicin/ifosfamide treatment Previously untreated gastrointestinal leiomyosarcoma allowed
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 3 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No active coronary disease requiring therapy Pulmonary: No severe pulmonary insufficiency Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other prior malignancy in past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No concurrent active infections No psychosis or mental disability that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior biological therapy and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: At least 7 days since prior hormonal therapy and recovered Radiotherapy: See Disease Characteristics Surgery: Not specified
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 Soft-Tissue Sarcomas
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 advanced or metastatic soft tissue sarcomas.
Read the detailed description
OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with locally advanced or metastatic gastrointestinal leiomyosarcomas or other soft tissue sarcomas.
OUTLINE: Patients are stratified by disease (gastrointestinal leiomyosarcomas vs other soft tissue sarcomas). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Responding patients who undergo surgery then receive an additional 4-6 courses (4 weeks/course).
PROJECTED ACCRUAL: A total of 34-78 patients (17-39 per stratum) will be accrued for this study.
- Being tested
- rubitecan
- Keywords
- adult leiomyosarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, small intestine leiomyosarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood leiomyosarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma
- Medical subject headings
- Gastrointestinal Stromal Tumors, Sarcoma, Leiomyosarcoma
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 startJun 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 Gastrointestinal Stromal TumorStudies 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
- NCT00005874
- Sponsor's protocol ID
- CDR0000067910
- Other IDs
- SUPERGEN-RFS2000-24, MDA-DM-99109
- 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 Soft-Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00005874
- Acronym / sponsor ID
- CDR0000067910
- Keywords
- adult leiomyosarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, small intestine leiomyosarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood leiomyosarcoma, gastrointestinal stromal tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 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 advanced or metastatic soft tissue sarcomas.
Detailed description
OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with locally advanced or metastatic gastrointestinal leiomyosarcomas or other soft tissue sarcomas.
OUTLINE: Patients are stratified by disease (gastrointestinal leiomyosarcomas vs other soft tissue sarcomas). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Responding patients who undergo surgery then receive an additional 4-6 courses (4 weeks/course).
PROJECTED ACCRUAL: A total of 34-78 patients (17-39 per stratum) will be accrued for this study.
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 Gastrointestinal Stromal Tumor and Sarcoma, 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.