UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Drugs used in chemotherapy 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: Phase I trial to study the effectiveness of UCN-01 and cisplatin in treating patients who have advanced or metastatic solid tumors.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00012194

Unspecified Adult Solid Tumor, Protocol Specific

TERMINATED PHASE1

Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

NCT00006465

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

NCT00004242

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor

NCT00005839

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

NCT00004913

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

* Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors.
* Assess the toxicity and potential antitumor activity of this regimen in these patients.
* Determine the pharmacokinetics of this regimen in these patients.

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

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

Cohorts of 1-6 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.

PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 1 year.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

7-hydroxystaurosporine

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed advanced or metastatic solid tumor incurable by surgery or other standard therapy
* Tumor site accessible by biopsy
* No brain metastasis

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* More than 3 months

Hematopoietic:

* WBC at least 4,500/mm3
* Absolute neutrophil count at least 2,000/mm3
* Platelet count at least 150,000/mm3

Hepatic:

* Bilirubin normal
* SGOT no greater than 2.5 times upper limit of normal

Renal:

* Creatinine normal
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No New York Heart Association class III or IV congestive heart failure

Other:

* No peripheral neuropathy greater than grade I
* No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) that would preclude study
* No other uncontrolled illness that would preclude study, including intolerance to vigorous hydration
* No medical, social, or psychological factors that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
* No greater than 2 prior chemotherapy regimens
* Prior cisplatin allowed if cumulative dose no greater than 400 mg/m2

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
* Recovered from any prior surgery

Other:

* At least 30 days since prior investigational drugs
* No other concurrent investigational drugs
* No other concurrent anticancer agents

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No