UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
A Phase I Study Of UCN-01 In Combination With Gemcitabine In Unresectable Or Metastatic Pancreatic Carcinoma
4 other identifiers
interventional
30
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 6, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedJanuary 23, 2013
January 1, 2013
4.1 years
June 6, 2002
January 22, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of toxicity
Up to 4 years
Pharmacokinetic profiles
Weeks 1-6 for UCN-01 and weeks 1 and 4 for intracellular gemcitabine
Recommended phase II doses
3 weeks
Secondary Outcomes (1)
Frequency, extent, and duration of any tumor responses
Up to 4 years
Study Arms (1)
Treatment (UCN-01, gemcitabine hydrochloride)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
- +38 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linus Ho
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2002
First Posted
January 27, 2003
Study Start
April 1, 2002
Primary Completion
May 1, 2006
Last Updated
January 23, 2013
Record last verified: 2013-01