Adenocarcinoma of the PancreasPhase 2NCT00331682
Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
A Phase 2 study testing alvocidib and docetaxel in people with Adenocarcinoma of the Pancreas and Recurrent Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer
- What is being tested?
- alvocidib and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Show all 42Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the response rate in patients with refractory, metastatic pancreatic cancer treated with weekly, sequential docetaxel and flavopiridol.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- alvocidib, docetaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alvocidibDrug
Also called FLAVO, flavopiridol, HMR 1275, L-868275
Given IV
docetaxelDrug
Also called RP 56976, Taxotere, TXT
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (docetaxel and alvocidib) | Experimental | 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. Receives: Drug: alvocidib; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate as Measured by RECIST Criteria
Objective response rate as measured by RECIST criteria
Measured: Up to 2 years
Secondary outcomes (2)
Time to Progression
Will be computed using Kaplan-Meier methods.
Measured: Between the start of treatment until the criteria for progression are met, assessed up to 2 years
Overall Survival
Will be computed using Kaplan-Meier methods.
Measured: Between the start of treatment until patient death, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eileen O'Reilly, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331682
- Sponsor's protocol ID
- NCI-2012-01471
- Other IDs
- 05-136, MSKCC-05136, NCI-6366, CDR0000472413, R01CA067819
- Status last verified
- Nov 2013
- First submitted
- 30 May 2006
- Last updated
- 28 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized Phase II Study of Alvocidib (Flavopiridol) in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer (NCI #6366)
- ClinicalTrials.gov ID
- NCT00331682
- Acronym / sponsor ID
- NCI-2012-01471
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 31 May 2006 (estimated)
- Results
- Posted 10 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the response rate in patients with refractory, metastatic pancreatic cancer treated with weekly, sequential docetaxel and flavopiridol.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (docetaxel and alvocidib) | Experimental | Drug: alvocidib, Drug: docetaxelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- 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
- Documented progression with measurable metastatic disease including any 1 of the following criteria:
- No documented brain metastases
- Karnofsky performance status (PS) 80-100% OR ECOG PS 0-1
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alvocidibAlso: FLAVO, flavopiridol, HMR 1275, L-868275Given IV | Drug | Treatment (docetaxel and alvocidib) |
| docetaxelAlso: RP 56976, Taxotere, TXTGiven IV | Drug | Treatment (docetaxel and alvocidib) |
Primary outcome
Objective Response Rate as Measured by RECIST Criteria
Time frame: Up to 2 years
Objective response rate as measured by RECIST criteria
2 secondary outcomes
Time to Progression
Time frame: Between the start of treatment until the criteria for progression are met, assessed up to 2 years
Overall Survival
Time frame: Between the start of treatment until patient death, assessed up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen O'Reilly principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alvocidib and docetaxel in people with Adenocarcinoma of the Pancreas and Recurrent Pancreatic Cancer, 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 42 inclusion and 0 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: finished, as of the sponsor's last update on 28 May 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate as Measured by RECIST Criteria (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2014.