Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00023855
PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing bortezomib and doxorubicin hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Wisconsin, Madison 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 I trial to study the effectiveness of combining PS-341 and doxorubicin in treating patients who have advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- bortezomib and doxorubicin hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Oct 2003
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced solid tumor for which no curative treatment exists
- Measurable or evaluable disease
- No brain metastases or primary brain tumors
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- MUGA at least 45%
Other:
- No serious active infection
- No pre-existing neuropathy grade 2 or greater
- No other concurrent illness that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No prior cumulative dose of doxorubicin exceeding 280 mg/m^2
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational or commercial agents for treatment of this malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
About this study
Official title: A Phase I and Pharmacodynamic Study of Proteasome Inhibitor, PS-341, in Combination With Doxorubicin in 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 combining PS-341 and doxorubicin in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of PS-341 in combination with doxorubicin in patients with advanced solid tumors.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of PS-341.
Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11; and doxorubicin IV on over 3-5 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-31 patients will be accrued for this study within 1 year.
- Being tested
- bortezomib, doxorubicin hydrochloride
- 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
- Primary completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James P. Thomas, MD, PhD, Study chair, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023855
- Sponsor's protocol ID
- CDR0000068870
- Other IDs
- P30CA014520, WCCC-CO-01901, NCI-3771
- Status last verified
- Sep 2015
- First submitted
- 13 Sep 2001
- Last updated
- 13 Dec 2019
- Results posted
- No
Publications
LoConte NK, Thomas JP, Alberti D, Heideman J, Binger K, Marnocha R, Utecht K, Geiger P, Eickhoff J, Wilding G, Kolesar J. A phase I pharmacodynamic trial of bortezomib in combination with doxorubicin in patients with advanced cancer. Cancer Chemother Pharmacol. 2008 Dec;63(1):109-15. doi: 10.1007/s00280-008-0719-5. Epub 2008 Mar 6.
PubMed 18322686
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I and Pharmacodynamic Study of Proteasome Inhibitor, PS-341, in Combination With Doxorubicin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00023855
- Acronym / sponsor ID
- CDR0000068870
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- Primary completion
- Oct 2003 (actual)
- First posted
- 27 Jan 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 use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of combining PS-341 and doxorubicin in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of PS-341 in combination with doxorubicin in patients with advanced solid tumors.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of PS-341.
Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11; and doxorubicin IV on over 3-5 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-31 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| bortezomib | Drug | – |
| doxorubicin hydrochloride | 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 13 Dec 2019.
- Results publication: PubMed 18322686LoConte NK, Thomas JP, Alberti D, Heideman J, Binger K, Marnocha R, Utecht K, Geiger P, Eickhoff J, Wilding G, Kolesar J. A phase I pharmacodynamic trial of bortezomib in combination with doxorubicin in patients with advanced cancer. Cancer Chemother Pharmacol. 2008 Dec;63(1):109-15. doi: 10.1007/s00280-008-0719-5. Epub 2008 Mar 6.
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.
James P. Thomas, MD, PhD study chair
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bortezomib and doxorubicin hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Wisconsin, Madison 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?
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 13 Dec 2019. 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 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?
On the ClinicalTrials.gov record for NCT00023855, which also lists 1 linked publication.
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 13 Dec 2019.