Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Houston, Texas 77030


Purpose:

Phase I trial to study the effectiveness of combining UCN-01 with gemcitabine in treating patients who have unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may help gemcitabine kill more cancer cells by making tumor cells more sensitive to the drug


Study summary:

PRIMARY OBJECTIVES: I. To determine the safety and toxicity profile of UCN-01 when given in combination with gemcitabine to patients with unresectable or metastatic adenocarcinoma of the pancreas. II. To characterize the pharmacokinetic profiles of gemcitabine and UCN-01 when given in combination and to correlate various measurements of UCN-01 with intracellular concentrations. III. To determine recommended doses of UCN-01 and gemcitabine in combination to be used in a planned subsequent phase II trial. SECONDARY OBJECTIVES: I. To record the frequency, extent, and duration of any tumor responses. II. To correlate serum alpha-1 acid glycoprotein (AGP) levels with UCN-01 pharmacokinetics and toxicity. OUTLINE: This is a dose-escalation study. Patients receive gemcitabine IV over 1-2 hours on days 1 and 8 followed by UCN-01 IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Sequential dose escalation of UCN-01 is followed by sequential dose escalation of gemcitabine. Cohorts of 3-6 patients receive escalating doses of UCN-01 and then gemcitabine until the maximum tolerated dose (MTD) of the combination 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. Once the MTD is determined, at least 6 patients are treated at the recommended phase II dose.


Criteria:

Inclusion Criteria: - Histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the pancreas - Unidimensionally measurable disease - At least 20 mm by conventional techniques - At least 10 mm by spiral CT scan - Tumor lesions in a previously irradiated area are not considered measurable - No known brain metastases - Patients with signs or symptoms of CNS metastasis at any time during screening must have a negative CT scan or MRI of the brain - Performance status - ECOG 0-2 - Performance status - Karnofsky 60-100% - More than 3 months - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count greater than 100,000/mm^3 - Bilirubin no greater than 1.5 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal - Creatinine normal - Creatinine clearance at least 60 mL/min - No prior coronary artery disease - No symptomatic cardiac dysfunction - No prior myocardial infarction - No active angina (even if controlled by medication) - No positive stress test - No uncontrolled arrhythmia - Left ventricular ejection fraction at least 45% - Patients with symptoms suggestive of coronary artery disease or arrhythmia must have no evidence of cardiac pathology - No symptomatic pulmonary dysfunction - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No prior allergic reactions attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents - No insulin-dependent diabetes mellitus - No other concurrent uncontrolled illness - No ongoing or active infections - No concurrent psychiatric illness - No other active malignancy - No other solid tumor within the past 5 years except neoplasia in situ or nonmelanomatous skin cancer - No social situations that would preclude study compliance - No concurrent over-the-counter biologics - No concurrent growth factors during the first study course - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No more than 2 prior chemotherapy regimens (e.g., gemcitabine and/or experimental agents) alone or in combination with radiotherapy as neoadjuvant or adjuvant therapy for resectable, unresectable, or metastatic disease - See Chemotherapy - At least 6 weeks since prior radiotherapy and recovered - Prior radiotherapy directed only at the primary tumor bed allowed - No prior radiotherapy to the mediastinum, pelvis, lower spine, or more than 20% of bone marrow - At least 4 weeks since prior major surgery - At least 4 weeks since prior investigational agents - Concurrent enrollment in non-therapy trials (e.g., quality of life) allowed - No concurrent herbal remedies - No concurrent treatment for another active malignancy - No concurrent warfarin for anticoagulation - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational or commercial anticancer agents or therapies


Study is Available At:


Original ID:

NCI-2012-02468


NCT ID:

NCT00039403


Secondary ID:

DM01-553


Study Acronym:


Brief Title:

UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer


Official Title:

A Phase I Study Of UCN-01 In Combination With Gemcitabine In Unresectable Or Metastatic Pancreatic Carcinoma


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Linus Ho
Principal Investigator
M.D. Anderson Cancer Center

Study Dates

Start Date:April 2002
Primary Completion Date:May 2006
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 22, 2013
First Received Date:June 6, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Frequency, extent, and duration of any tumor responses
Time Frame:Up to 4 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Recommended phase II doses
Time Frame:3 weeks
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Pharmacokinetic profiles
Time Frame:Weeks 1-6 for UCN-01 and weeks 1 and 4 for intracellular gemcitabine
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Incidence of toxicity
Time Frame:Up to 4 years
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:7-hydroxystaurosporine
Description:Given IV
Arm Name:Treatment (UCN-01, gemcitabine hydrochloride)
Other Name:UCN-01
Intervention Type:Drug
Name:gemcitabine hydrochloride
Description:Given IV
Arm Name:Treatment (UCN-01, gemcitabine hydrochloride)
Other Name:dFdC
Intervention Type:Other
Name:pharmacological study
Description:Correlative studies
Arm Name:Treatment (UCN-01, gemcitabine hydrochloride)
Other Name:pharmacological studies
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Treatment (UCN-01, gemcitabine hydrochloride)

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (UCN-01, gemcitabine hydrochloride)
Description:Patients receive gemcitabine IV over 1-2 hours on days 1 and 8 followed by UCN-01 IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Sequential dose escalation of UCN-01 is followed by sequential dose escalation of gemcitabine. Cohorts of 3-6 patients receive escalating doses of UCN-01 and then gemcitabine until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at w

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.