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Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00331682
Enrollment
10
Registered
2006-05-31
Start date
2006-03-31
Completion date
2008-05-31
Last updated
2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

Brief summary

Drugs used in chemotherapy, such as docetaxel and flavopiridol, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Flavopiridol may also help docetaxel work better by making tumor cells more sensitive to the drug. This phase II trial is studying how well giving docetaxel followed by flavopiridol works in treating patients with refractory metastatic pancreatic cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the response rate in patients with refractory, metastatic pancreatic cancer treated with weekly, sequential docetaxel and flavopiridol. SECONDARY OBJECTIVES: I. Determine the time to progression and overall survival of patients treated with this regimen. II. Assess the toxicity of this regimen. OUTLINE: This is a non-randomized, open-label, prospective study. Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Interventions

DRUGalvocidib

Given IV

DRUGdocetaxel

Given IV

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologically or cytologically confirmed adenocarcinoma of the pancreas * Evidence of metastatic disease * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques or as ≥ 10 mm with spiral CT scan * The primary site is not a measurable lesion * Documented progression with measurable metastatic disease including any 1 of the following criteria: * Receiving adjuvant therapy for resected disease * Receiving therapy for locally advanced disease * Within 3 months of completing adjuvant therapy or therapy for locally advanced disease * On 1 prior regimen in the metastatic setting * No documented brain metastases * Karnofsky performance status (PS) 80-100% OR ECOG PS 0-1 * WBC ≥ 2,500/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT \< 2.5 times ULN * Creatinine normal OR creatinine clearance ≥ 60 mL/min * Alkaline phosphatase ≤ 5 times ULN * No history of allergic reactions to compounds of similar chemical orbiological composition to flavopiridol * No known allergy to docetaxel or medications formulated in polysorbate 80 (Tween 80) * No uncontrolled diabetes * No uncontrolled intercurrent illness including, but not limited to any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia or myocardial infarction within the past 6 months * Rate-controlled atrial fibrillation stable for ≥ 6 months allowed * Psychiatric illness or social situations that would limit compliance with study requirements * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No peripheral neuropathy \> grade 1 * No immune deficiency * Atl east 2 weeks since prior chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin C) and recovered * At least 2 weeks since prior targeted therapy (e.g., antiangiogenic therapy \[e.g., bevacizumab\] or epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[e.g., erlotinib hydrochloride\]) and recovered * At least 4 weeks since prior radiation therapy * No prior docetaxel or flavopiridol * No other concurrent chemotherapy or investigational agents * No other concurrent anticancer agents or therapies * No concurrent commonly used vitamins, antioxidants, orherbal preparations or supplements * Single-tablet multivitamin allowed * No concurrent combination antiretroviral therapy for HIV-positive patients

Design outcomes

Primary

MeasureTime frameDescription
Objective Response Rate as Measured by RECIST CriteriaUp to 2 yearsObjective response rate as measured by RECIST criteria

Secondary

MeasureTime frameDescription
Time to ProgressionBetween the start of treatment until the criteria for progression are met, assessed up to 2 yearsWill be computed using Kaplan-Meier methods.
Overall SurvivalBetween the start of treatment until patient death, assessed up to 2 yearsWill be computed using Kaplan-Meier methods.

Countries

United States

Participant flow

Participants by arm

ArmCount
Docetaxel and Flavopiridol
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. flavopiridol: Given IV docetaxel: Given IV
9
Total9

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event1

Baseline characteristics

CharacteristicDocetaxel and Flavopiridol
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
Age, Continuous66 years
STANDARD_DEVIATION 21.21320344
Region of Enrollment
United States
9 participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
9 / 9
serious
Total, serious adverse events
10 / 10

Outcome results

Primary

Objective Response Rate as Measured by RECIST Criteria

Objective response rate as measured by RECIST criteria

Time frame: Up to 2 years

ArmMeasureGroupValue (NUMBER)
Docetaxel and FlavopiridolObjective Response Rate as Measured by RECIST CriteriaProgression of Disease6 participants
Docetaxel and FlavopiridolObjective Response Rate as Measured by RECIST CriteriaStable Disease3 participants
Secondary

Overall Survival

Will be computed using Kaplan-Meier methods.

Time frame: Between the start of treatment until patient death, assessed up to 2 years

ArmMeasureValue (MEDIAN)
Docetaxel and FlavopiridolOverall Survival4.2 months
Secondary

Time to Progression

Will be computed using Kaplan-Meier methods.

Time frame: Between the start of treatment until the criteria for progression are met, assessed up to 2 years

ArmMeasureValue (MEDIAN)
Docetaxel and FlavopiridolTime to Progression8 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026