Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003709
Chemotherapy in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing carbendazim in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The University of Texas Health Science Center at San Antonio at 2 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 I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- carbendazim
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 1998to Nov 2000
- Phase
- Phase 1
- 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: Pathologically proven advanced solid tumors for which no standard therapy exists or that has progressed or recurred following prior therapy Measurable or evaluable disease No hematological malignancies (e.g., leukemia or lymphoma) No known brain or leptomeningeal disease, unless lesions were previously irradiated, currently not being treated with corticosteroids, and have no clinical symptoms
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if due to tumor) PT and aPTT no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No unstable atrial or ventricular arrhythmias that require medication No ischemic events within 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychiatric disorders No history of seizure disorders No other severe concurrent disease No history of ulcers or abnormalities that would interfere with carbendazim absorption No history of hypersensitivity to PEG-formulated medications (including cyclosporine or etoposide)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: No prior gastrointestinal surgery that would interfere with carbendazim absorption Other: No concurrent use of phenytoin, phenobarbital, valproic acid, or other antiepileptic prophylaxis No concurrent scheduled antacids, such as H2 blockers (e.g., cimetidine or ranitidine) or hydrogen pump inhibitors (e.g., omeprazole), or cisapride
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
San Antonio Cancer Institute
San Antonio, Texas, 78229
About this study
Official title: Phase I and Pharmacokinetic Study of FB-642 Administered Orally on a Weekly Schedule to Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of oral carbendazim in patients with advanced solid tumors. II. Determine the qualitative and quantitative toxic effects of oral carbendazim in these patients. III. Characterize the pharmacokinetic profile of oral carbendazim in these patients. IV. Assess the recommended dose of oral carbendazim to be used in phase II studies. V. Determine preliminary evidence of antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients treated at a given dose level, 3 additional patients will be entered at the same dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed for up to 30 days posttreatment.
PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.
- Being tested
- carbendazim
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbendazimDrug
Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients treated at a given dose level, 3 additional patients will be entered at the same dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed for up to 30 days posttreatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2004 (estimated)
- Study startOct 1998
- Primary completionNov 2000
- Study completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Therapy and Research Center, Texas
- Responsible party
- Sponsor
- Investigators
- Anthony W. Tolcher, MD, Study chair, San Antonio Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003709
- Sponsor's protocol ID
- CDR0000066817
- Other IDs
- P30CA054174, UTHSC-9895011080, ILEX-FB-642-101, SACI-IDD-98-21, NCI-V98-1503
- Status last verified
- Aug 2012
- First submitted
- 1 Nov 1999
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I and Pharmacokinetic Study of FB-642 Administered Orally on a Weekly Schedule to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00003709
- Acronym / sponsor ID
- CDR0000066817
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Therapy and Research Center, Texas
- Study start
- Oct 1998
- Primary completion
- Nov 2000 (actual)
- Study completion
- Nov 2000 (actual)
- First posted
- 17 Aug 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 I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of oral carbendazim in patients with advanced solid tumors. II. Determine the qualitative and quantitative toxic effects of oral carbendazim in these patients. III. Characterize the pharmacokinetic profile of oral carbendazim in these patients. IV. Assess the recommended dose of oral carbendazim to be used in phase II studies. V. Determine preliminary evidence of antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients treated at a given dose level, 3 additional patients will be entered at the same dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed for up to 30 days posttreatment.
PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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 |
|---|---|---|
| carbendazimPatients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients treated at a given dose level, 3 additional patients will be entered at the same dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed for up to 30 days posttreatment. | 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 9 Aug 2012.
Related trials for Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
Assessment Tool for Older Patients With Cancer
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
Recruiting
Copenhagen Prospective Personalized Oncology (CoPPO)
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
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.
Anthony W. Tolcher, MD study chair
San Antonio Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carbendazim in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The University of Texas Health Science Center at San Antonio at 2 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 9 Aug 2012.