Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00072228
Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing gemcitabine, soblidotin and chemotherapy in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Daiichi Pharmaceuticals at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. 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?
- gemcitabine, soblidotin and chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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:
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- Minimally pretreated
- Not refractory to prior gemcitabine therapy
- No disease progression during initial treatment with gemcitabine
- No symptomatic brain metastases
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/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- Ejection fraction at least 40% by MUGA
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric disorder that would preclude study consent or compliance
- No concurrent severe or uncontrolled underlying medical disease unrelated to the tumor that would compromise patient safety or affect study outcome
- No hypersensitivity to gemcitabine
- No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off all therapy for that disease for at least 2 years
- No serious infection
- No grade 2 or greater neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent anticancer biologic therapy
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No other concurrent anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Recovered from prior radiotherapy
- No concurrent anticancer radiotherapy
- Concurrent localized palliative radiotherapy to a non-indicator lesion for pain control allowed only if other methods of pain control are ineffective
Surgery
- At least 4 weeks since prior major surgery and recovered
Other
- More than 28 days since prior investigational drugs, including analgesics or antiemetics
- At least 4 weeks since prior myelosuppressive therapy
- No other concurrent anticancer therapy
- No other concurrent anticancer cytotoxic therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
About this study
Official title: Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors.
- Determine the dose-limiting toxic effects of this regimen in these patients.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study.
Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival every 3 months after completion of study therapy.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.
- Being tested
- gemcitabine, soblidotin, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
soblidotinDrug
chemotherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Daiichi Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert L. DeJager, MD, FACP, Study chair, Daiichi Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072228
- Sponsor's protocol ID
- DAIICHI-1027A-PRT008
- Other IDs
- CDR0000339345, CPMC-IRB-20031085, NCT00072228
- Status last verified
- Dec 2006
- First submitted
- 4 Nov 2003
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00072228
- Acronym / sponsor ID
- DAIICHI-1027A-PRT008
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Lead sponsor
- Daiichi PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 6 Nov 2003 (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, such as soblidotin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors.
- Determine the dose-limiting toxic effects of this regimen in these patients.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study.
Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival every 3 months after completion of study therapy.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| gemcitabine | Drug | – |
| soblidotin | Drug | – |
| chemotherapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
Robert L. DeJager, MD, FACP study chair
Daiichi Pharmaceuticals
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 gemcitabine, soblidotin and chemotherapy in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Daiichi Pharmaceuticals 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: withdrawn, as of the sponsor's last update on 10 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 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 was withdrawn before enrolling participants, so there are no results.
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 10 Jul 2013.