Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00036777
UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing carboplatin, 7-hydroxystaurosporine and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of combining UCN-01 with carboplatin in treating patients who have advanced solid tumors. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. 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?
- carboplatin, 7-hydroxystaurosporine and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Oct 2004
- 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
Who may be able to join
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- At least 4 weeks since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included BCNU or mitomycin C; include site/total dose for prior radiation exposure as needed (e.g., no more than 3000 cGy to fields including substantial marrow)
- ECOG performance status =< 2 (Karnofsky >= 60%)
- Life expectancy of greater than 12 weeks
- Leukocytes >= 3,000/microl
- Absolute neutrophil count >= 1,500/microl
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- Platelets >= 100,000/microl
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) >= 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases are eligible providing the brain metastases are, in the opinion of the site investigator, asymptomatic or clinically stable after treatment with surgery and/or radiation therapy; patients should not require steroids or antiseizure medications and should have fully recovered from all therapy; at least two weeks should elapse between completion of any treatment for brain metastases (surgery, CNS irradiation) and commencement of protocol therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to UCN-01 or other agents used in study
- Because of cardiopulmonary toxicity seen in patients on other studies, patients with a symptomatic cardiac disease should be excluded; patients with a history of coronary artery disease or mediastinal radiation should undergo testing of ventricular function (cardiac echocardiogram, MUGA or equivalent) and are eligible if LVEF is >= 45%; if there is a history of prior pulmonary disease then pulmonary function tests should be performed and patients are eligible if FEV1 >= 1 liter
- Because UCN-01 may cause hyperglycemia, patients with insulin dependent diabetes mellitus should be excluded
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this; breastfeeding should be discontinued if the mother is treated with UCN-01
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
- Other drugs: Though not an exclusion criteria, every effort should be made to avoid drugs which may bind alpha-acid glycoprotein (AGP)
- Patients with a history of severe allergic reactions to cisplatin or carboplatin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201-1595
About this study
Official title: A Phase 1 Study of UCN-01 in Combination With Carboplatin in Advanced Solid Tumors
Phase I trial to study the effectiveness of combining UCN-01 with carboplatin in treating patients who have advanced solid tumors. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with carboplatin may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose, dose limiting toxicity and other toxicities of UCN-01 when combined with carboplatin.
II. Preliminarily evaluate the antitumor effect of the combination of carboplatin and UCN-01.
III. Determine the pharmacokinetics of UCN-01 and carboplatin.
OUTLINE: This is a dose-escalation study.
Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 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.
- Being tested
- carboplatin, 7-hydroxystaurosporine, pharmacological study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Also called Carboplat, CBDCA, JM-8, Paraplat
Given IV
7-hydroxystaurosporineDrug
Also called UCN-01
Given IV
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (carboplatin, 7-hydroxystaurosporine) | Experimental | Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 until the 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. Receives: Drug: carboplatin; Drug: 7-hydroxystaurosporine; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of UCN-01 when combined with carboplatin determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria (CTC)
Measured: 21 days
Secondary outcomes (3)
Response rate
Reported with 95% confidence intervals.
Measured: Up to 3 years
Survival
Estimated utilizing Kaplan-Meier analysis.
Measured: From the date of first treatment until death or last follow up, assessed up to 3 years
Pharmacokinetics parameters of UCN-01
Will be determined using model independent and compartmental modeling methods. Will include, but not be limited too; the maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC), terminal elimination half-life (t1/2), clearance (Cl), and volume of distribution (Vd).
Measured: Prior to and at 0.5, 1, 2, and 3 hours after the start of the infusion and at 2, 4, 8, 24, 48 hours, and 7, and 21 days after the end of the infusion
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 startMar 2002
- Primary completionOct 2004
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.
- More trials run by National Cancer Institute (NCI)The 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Martin Edelman, Principal investigator, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036777
- Sponsor's protocol ID
- NCI-2013-00042
- Other IDs
- UMGCC 0143, MSGCC-0143, NCI-5533, CDR0000069321, U01CA069854
- Status last verified
- Jun 2013
- First submitted
- 13 May 2002
- Last updated
- 1 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of UCN-01 in Combination With Carboplatin in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00036777
- Acronym / sponsor ID
- NCI-2013-00042
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2002
- Primary completion
- Oct 2004 (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.
Phase I trial to study the effectiveness of combining UCN-01 with carboplatin in treating patients who have advanced solid tumors. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with carboplatin may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose, dose limiting toxicity and other toxicities of UCN-01 when combined with carboplatin.
II. Preliminarily evaluate the antitumor effect of the combination of carboplatin and UCN-01.
III. Determine the pharmacokinetics of UCN-01 and carboplatin.
OUTLINE: This is a dose-escalation study.
Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (carboplatin, 7-hydroxystaurosporine) | Experimental | Drug: carboplatin, Drug: 7-hydroxystaurosporine, Other: pharmacological studyPatients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 until the 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- At least 4 weeks since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included BCNU or mitomycin C; include site/total dose for prior radiation exposure as needed (e.g., no more than 3000 cGy to fields including substantial marrow)
- ECOG performance status =< 2 (Karnofsky >= 60%)
- Life expectancy of greater than 12 weeks
- Leukocytes >= 3,000/microl
Key exclusion criteria (11 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases are eligible providing the brain metastases are, in the opinion of the site investigator, asymptomatic or clinically stable after treatment with surgery and/or radiation therapy; patients should not require steroids or antiseizure medications and should have fully recovered from all therapy; at least two weeks should elapse between completion of any treatment for brain metastases (surgery, CNS irradiation) and commencement of protocol therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to UCN-01 or other agents used in study
- Because of cardiopulmonary toxicity seen in patients on other studies, patients with a symptomatic cardiac disease should be excluded; patients with a history of coronary artery disease or mediastinal radiation should undergo testing of ventricular function (cardiac echocardiogram, MUGA or equivalent) and are eligible if LVEF is >= 45%; if there is a history of prior pulmonary disease then pulmonary function tests should be performed and patients are eligible if FEV1 >= 1 liter
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 |
|---|---|---|
| carboplatinAlso: Carboplat, CBDCA, JM-8, ParaplatGiven IV | Drug | Treatment (carboplatin, 7-hydroxystaurosporine) |
| 7-hydroxystaurosporineAlso: UCN-01Given IV | Drug | Treatment (carboplatin, 7-hydroxystaurosporine) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (carboplatin, 7-hydroxystaurosporine) |
Primary outcome
Maximum tolerated dose of UCN-01 when combined with carboplatin determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria (CTC)
Time frame: 21 days
3 secondary outcomes
Response rate
Time frame: Up to 3 years
Survival
Time frame: From the date of first treatment until death or last follow up, assessed up to 3 years
Pharmacokinetics parameters of UCN-01
Time frame: Prior to and at 0.5, 1, 2, and 3 hours after the start of the infusion and at 2, 4, 8, 24, 48 hours, and 7, and 21 days after the end of the infusion
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 1 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.
Martin Edelman principal investigator
University of Maryland Greenebaum 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 carboplatin, 7-hydroxystaurosporine and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) 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?
The sponsor lists 12 inclusion and 11 exclusion criteria. 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 1 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 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.
What does the primary outcome measure?
Maximum tolerated dose of UCN-01 when combined with carboplatin determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria (CTC) (time frame: 21 days). It is what the study was designed to measure, not a finding.
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 1 Jul 2013.