Breast CancerPhase 1NCT00036790
Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
A Phase 1 study testing doxorubicin hydrochloride and motexafin gadolinium in people with Breast Cancer and Chronic Myeloproliferative Disorders, run by University of Wisconsin, Madison 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. Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Chronic Myeloproliferative Disorders, Colorectal Cancer
- What is being tested?
- doxorubicin hydrochloride and motexafin gadolinium
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Feb 2002to Oct 2005
- 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 confirmed advanced malignancy that is considered incurable
- Recurrent or metastatic disease
- Relapsed solid tumors include, but are not limited to the following sites:
- Lung
- Breast
- Colon
- Prostate
- Head and neck
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex
- Not specified
Menopausal status
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
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 mg/dL
- AST and ALT no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- LVEF greater than 45% at rest
- No prior myocardial infarction
- No congestive heart failure
- No clinically significant ventricular arrhythmias
Other:
- No history of HIV infection
- No history of porphyria
- No glucose-6-phosphate dehydrogenase deficiency
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 28 days since prior chemotherapy
- No prior lifetime cumulative doxorubicin exposure of more than 300 mg/m^2
- No other concurrent cytotoxic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 28 days since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- No concurrent surgery
Other:
- At least 14 days since prior multidrug resistance-modulating drugs (e.g., PSC833 or cyclosporine)
- No other concurrent antineoplastic or investigational agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Evaluate the tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 groups.
Group A:
- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on days 1, 8, 9, and 10 and doxorubicin IV over 15 minutes on day 8.
- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes.
- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. Treatment repeats every 21 days.
Group B:
- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on day 1 and doxorubicin IV over 15 minutes on day 8.
- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3.
- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin and motexafin gadolinium as in group A.
Treatment in both groups continues for up to 6 courses in the absence of disease progression, unacceptable toxicity, or a cumulative doxorubicin dose of 450 mg/m^2.
Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 and 2 months.
PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for this study.
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Colorectal Cancer, Head and Neck Cancer, Leukemia, Lung Cancer
- Being tested
- doxorubicin hydrochloride, motexafin gadolinium
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, Waldenstrom macroglobulinemia, stage III multiple myeloma, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, small intestine lymphoma, unspecified adult solid tumor, protocol specific, chronic phase chronic myelogenous leukemia
- Medical subject headings
- Breast Neoplasms, Myeloproliferative Disorders, Colorectal Neoplasms, Head and Neck Neoplasms, Leukemia, Lung Neoplasms, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motexafin gadoliniumDrug
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 startFeb 2002
- Primary completionOct 2005
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.
- 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
- Markus Renschler, MD, Study chair, Pharmacyclics LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036790
- Sponsor's protocol ID
- CDR0000069322
- Other IDs
- P30CA014520, WCCC-CO-01910, PCI-PCYC-0207, NCI-G02-2061
- Status last verified
- Sep 2015
- First submitted
- 13 May 2002
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00036790
- Acronym / sponsor ID
- CDR0000069322
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Colorectal Cancer, Head and Neck Cancer, Leukemia, Lung Cancer
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, isolated plasmacytoma of bone, extramedullary plasmacytoma
- 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
- Feb 2002
- Primary completion
- Oct 2005 (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. Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Evaluate the tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 groups.
Group A:
- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on days 1, 8, 9, and 10 and doxorubicin IV over 15 minutes on day 8.
- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes.
- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. Treatment repeats every 21 days.
Group B:
- Course 1: Patients receive motexafin gadolinium IV over 30 minutes on day 1 and doxorubicin IV over 15 minutes on day 8.
- Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3.
- Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin and motexafin gadolinium as in group A.
Treatment in both groups continues for up to 6 courses in the absence of disease progression, unacceptable toxicity, or a cumulative doxorubicin dose of 450 mg/m^2.
Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 and 2 months.
PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for this study.
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 |
|---|---|---|
| doxorubicin hydrochloride | Drug | – |
| motexafin gadolinium | 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 17 Dec 2019.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Markus Renschler, MD study chair
Pharmacyclics LLC.
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 doxorubicin hydrochloride and motexafin gadolinium in people with Breast Cancer and Chronic Myeloproliferative Disorders, run by University of Wisconsin, Madison 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 17 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 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 17 Dec 2019.