Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00095914
Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing paclitaxel and paclitaxel albumin-stabilized nanoparticle formulation in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- paclitaxel and paclitaxel albumin-stabilized nanoparticle formulation
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant solid tumor
- Considered incurable
- Locally advanced or metastatic disease
- Likely to be responsive to taxane-based therapy
- Patients who are refractory to prior paclitaxel are ineligible
- No symptomatic or untreated brain metastasis or carcinomatous meningitis
- No patients who are unable to remain free of corticosteroid therapy for > 4 weeks due to CNS disease
- No previously untreated locally advanced breast cancer
- No hematologic malignancy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin normal
- ALT and AST ≤ 1.5 times upper limit of normal
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- LVEF ≥ 40%
- No clinical signs or symptoms of heart failure
- No symptomatic congestive heart failure
- No unstable angina pectoris
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to paclitaxel (e.g., docetaxel, Cremophor^® EL [CrEL], polysorbate 80 [Tween 80], or CrEL-containing medications [e.g., cyclosporine])
- No history of seizure disorder requiring anticonvulsant therapy
- No active serious infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent filgrastim (G-CSF) during courses 1 and 2
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- At least 2 weeks since prior hormonal therapy
- Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed
Radiotherapy
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 2 weeks since prior drugs, herbal preparations, or dietary supplements known to influence CYP3A4 (e.g., phenytoin, rifampin, Hypericum perforatum [St. John's wort], garlic supplements, or grapefruit juice) and/or CYP2C8
- No concurrent substances known or likely to interfere with the pharmacokinetics of paclitaxel (e.g., verapamil or cyclosporine)
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel.
Secondary
- Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients.
- Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients.
- Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen.
OUTLINE: This is a randomized, pilot study.
- Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22.
- Arm II: Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22.
- Courses 3 and beyond: All patients receive ABI-007 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Being tested
- paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
paclitaxel albumin-stabilized nanoparticle formulationDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startSep 2004
- Primary completionMay 2007
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- William D. Figg, PharmD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095914
- Sponsor's protocol ID
- 040280
- Other IDs
- 04-C-0280, ABI-CA019, CDR0000393782
- Status last verified
- Mar 2012
- First submitted
- 9 Nov 2004
- Last updated
- 15 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00095914
- Acronym / sponsor ID
- 040280
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- Primary completion
- May 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel.
Secondary
- Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients.
- Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients.
- Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen.
OUTLINE: This is a randomized, pilot study.
- Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22.
- Arm II: Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22.
- Courses 3 and beyond: All patients receive ABI-007 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| paclitaxel | Drug | – |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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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.
William D. Figg, PharmD study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing paclitaxel and paclitaxel albumin-stabilized nanoparticle formulation in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) 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?
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 15 Mar 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 15 Mar 2012.