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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00012194

7-hydroxystaurosporine and Cisplatin in Treating Patients With Advanced Malignant Solid Tumors

A Phase 1 study testing 7-hydroxystaurosporine, cisplatin and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase I trial to study the effectiveness of combining UCN-01 with cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
7-hydroxystaurosporine, cisplatin and laboratory biomarker analysis
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 2001to Jan 2007
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

  • Advanced or metastatic, histologcally/cytologically confirmed malignant solid tumor, not expected to clinically benefit from standard therapy
  • Life expectancy greater than 3 months
  • Previous chemotherapy and/or radiotherapy must have been completed at least four weeks (six weeks for prior treatment with mitomycin or nitrosoureas) and patients should have recovered from all toxicities of that therapy before treatment under this protocol
  • All patients must have recovered from any surgical procedure
  • Serum creatinine must be within the institutional limits of normal and an estimated creatinine clearance of >= 60 ml/min
  • Normal bilirubin is required
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  • SGOT/AST must be less than or equal to 2.5 times the upper limit of institutional normal
  • WBC >= 4000/mm^3
  • Absolute neutrophil count >= 2000/mm^3
  • Platelet count >= 150,000/mm^3
  • Patients must have a Karnofsky Performance Status of 60% or greater
  • Subjects who are fertile must use a medically acceptable contraceptive throughout the treatment period and for three months following cessation of treatment; subjects must be made aware, before entering this trial, of the risk in becoming pregnant or in fathering children
  • A signed informed consent (approved by the IRB) must be obtained prior to trial entry
  • Tumor site accessible for both pre-treatment and post-treatment biopsy is preferred during dose-finding, and is required for patients entering the expanded cohort at the MTD
  • All patients require a central indwelling venous catheter prior to treatment under this protocol

Who cannot join

  • Peripheral neuropathy > grade I
  • Any prior mediastinal radiotherapy
  • Any history of coronary artery disease
  • Class III or IV congestive heart failure according to the New York Heart Classification
  • History of allergic reactions to appropriate diuretics or antiemetics (e.g., 5-HT3 antagonists) to be administered in conjunction with protocol directed chemotherapy
  • Brain metastasis
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  • Uncontrolled intercurrent illness that would preclude tolerance and completion of the protocol treatment, including vigorous hydration prior and subsequent to cisplatin therapy
  • Lactating or pregnant women are excluded to avoid potential harm to the unborn child or infant; documentation of a negative, serum beta-HCG pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause
  • Receipt of any investigational drug within 30 days before beginning treatment with study drug
  • Medical, social, or psychological factors that would prevent the patient from completing the treatment protocol
  • Patients with clinically significant hearing loss

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors

Phase I trial to study the effectiveness of combining UCN-01 with cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help cisplatin kill more cancer cells by making tumor cells more sensitive to the drug.

Read the detailed description

OBJECTIVES:

  1. To establish the maximum tolerated dose (MTD) of cisplatin in combination with UCN-01 in patients with advanced malignancies.

II. To assess the toxicity and observe the potential antitumor activity of UCN-01 plus cisplatin in advanced malignancies at each dose level studies.

III. To determine the pharmacokinetics of UCN-01 and cisplatin on this treatment schedule.

IV. To perform laboratory correlative studies to investigate intermediate molecular markers of the activity of UCN-01 and cisplatin at the cellular level.

OUTLINE: This is a dose-escalation study of cisplatin.

Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours on day 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of cisplatin 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 every 2-3 months for at least 1 year.

Being tested
7-hydroxystaurosporine, cisplatin, laboratory biomarker analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7-hydroxystaurosporineDrug

    Also called UCN-01

    Given IV

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00012194
Study groupRoleWhat they receive
Treatment (7-hydroxystaurosporine, cisplatin)ExperimentalPatients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours on day 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: 7-hydroxystaurosporine; Drug: cisplatin; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of cisplatin defined as the highest dose level in which six patients have been evaluated for toxicity with no more than one patient experiencing DLT attributable to the study drugs

    Graded using the NCI CTCAE.

    Measured: 4 weeks

  2. Toxicity observed at each dose level, graded using the NCI CTCAE

    Summarized in terms of type, severity, time of onset, duration, and reversibility or outcome.

    Measured: Up to 7 years

Secondary outcomes (4)

  1. Objective tumor response

    Summarized at each dose level, and the number and percent responding combined across dose levels.

    Measured: Up to 7 years

  2. Overall survival

    Summarized with Kaplan-Meier plots.

    Measured: From registration to time of death due to any cause, assessed up to 7 years

  3. Time to treatment failure

    Summarized with Kaplan-Meier plots.

    Measured: From registration to the first observation of disease progression, death due to any cause, or early discontinuation of treatment, assessed up to 7 years

  4. Duration of response

    Summarized with Kaplan-Meier plots.

    Measured: Up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2001
  3. Primary completionJan 2007

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00012194
Sponsor's protocol ID
NCI-2012-03129
Other IDs
DMS 9934, DMS-9934, NCI-2331
Status last verified
Jul 2013
First submitted
3 Mar 2001
Last updated
9 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 7-hydroxystaurosporine, cisplatin and laboratory biomarker analysis 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 15 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: stopped early, as of the sponsor's last update on 9 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 was stopped early. Results are not available in the source record.

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?

MTD of cisplatin defined as the highest dose level in which six patients have been evaluated for toxicity with no more than one patient experiencing DLT attributable to the study drugs (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00012194.

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 Jul 2013.

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