Advanced Solid TumorsPhase 1NCT01170871
Ixabepilone and Pemetrexed/Solid Tumors
A Phase 1 study testing Ixabepilone and Pemetrexed in people with Advanced Solid Tumors, run by University of Southern California at 2 sites in United States.
Trial summary
The purpose of the study is to determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors and to obtain preliminary information regarding the activity of this combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Ixabepilone and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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
Who may be able to join
- SWOG performance status of 0-2.
- Projected life expectancy of at least 3 months.
- Female and or male age 18 years and over.
- Provision of informed consent prior to any study-related procedures.
- Female patients must not be pregnant due to the potential mutagenicity. and teratogenicity of this treatment. A pregnancy test must be administered 7 days prior to administration of therapy to women of childbearing potential.
- Negative pregnancy test for women of childbearing potential.
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- Patients must agree to use some form of contraception while on this study at initiation and for the duration of participation in the study. Sexually active males must also use a reliable and appropriate method of contraception. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Patients must have recovered from acute toxicities from previous surgery, chemotherapy or radiation therapy.
- Adequate organ function defined as:
- ANC > 1500/mm3
- Platelet count > 100,000 cells/mm3
- Hemoglobin > 9.0g/dL
- Serum creatinine < 1.5 mg/dl or creatinine clearance > 45 mL/minute
- (calculated by Cockcroft-Gault formula.)
- Hepatic function: Patients must have adequate liver functions: AST or ALT < 2.5 X upper limit of normal (ULN), alkaline phosphatase < 2.5 X upper limit of normal. In patients with bone metastasis and no evidence of liver metastasis and bilirubin < upper limit of normal an alkaline phosphatase < 5 ULN will be allowed
- Serum Bilirubin < 1.5 mg/dL
- Peripheral neuropathy grade 0-1.
- No other concomitant therapy directed at the cancer is allowed.
- The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
Who cannot join
- Laboratory results:
- Serum bilirubin > 1.5 the upper limit of reference range (ULRR)
- Serum creatinine >1.5 x ULRR or creatinine clearance < 45 mL/minute (calculated by Cockcroft-Gault formula)
- Women who are currently pregnant or breast feeding.
- Receipt of any investigational agents within 30 days prior to commencing study treatment.
- Last dose of prior chemotherapy discontinued less than 4 weeks before the start of study therapy.
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- Last radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy.
- Prior radiation must not have included ≥ 30% of major bone marrow containing areas (pelvis, lumbar spine).
- Any unresolved toxicity greater than CTC grade 1 from previous anti- cancer therapy, excluding alopecia.
- CTC Grade 1 or greater neuropathy (motor or sensory) at study entry.
- Hematologic function with absolute neutrophils ≤ 1500/mm3 and/or platelets < 100,000/mm 3.
- Hepatic function with serum bilirubin greater than the upper institutional limits of normal, ALT and AST > 2.5 times the upper institutional limits of normal.
- Presence of third space fluid which cannot be controlled by drainage.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles County+University of Southern California Medical Center
Los Angeles, California, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase I Clinical Trial of Ixabepilone and Pemetrexed in Advanced Solid Tumors
The purpose of the study is to determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors and to obtain preliminary information regarding the activity of this combination.
This research study is for research participants who have confirmed metastatic or unresectable solid tumors (lung, breast, ovary, cervix, uterus, mesothelioma, and prostate) for which standard curative or palliative measures do not exist or no longer effective.
- Conditions
- Advanced Solid Tumors
- Being tested
- Ixabepilone, Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxabepiloneDrug
PemetrexedDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Escalating doses of Ixabepilone and Pemetrexed Receives: Drug: Ixabepilone; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors.
Measured: weekly
Secondary outcomes (1)
Response Rate
Measured: every 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
Why it stopped: Sponsor withdrew support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Investigators
- Agustin Garcia, MD, Principal investigator, Univrsity of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170871
- Sponsor's protocol ID
- 0C-08-2
- Status last verified
- May 2014
- First submitted
- 4 Nov 2009
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Ixabepilone and Pemetrexed in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01170871
- Acronym / sponsor ID
- 0C-08-2
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdrew support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- First posted
- 27 Jul 2010 (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.
The purpose of the study is to determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors and to obtain preliminary information regarding the activity of this combination.
This research study is for research participants who have confirmed metastatic or unresectable solid tumors (lung, breast, ovary, cervix, uterus, mesothelioma, and prostate) for which standard curative or palliative measures do not exist or no longer effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Ixabepilone, Drug: PemetrexedEscalating doses of Ixabepilone and Pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- SWOG performance status of 0-2.
- Projected life expectancy of at least 3 months.
- Female and or male age 18 years and over.
- Provision of informed consent prior to any study-related procedures.
- Female patients must not be pregnant due to the potential mutagenicity. and teratogenicity of this treatment. A pregnancy test must be administered 7 days prior to administration of therapy to women of childbearing potential.
Key exclusion criteria (13 listed)
- Laboratory results:
- Women who are currently pregnant or breast feeding.
- Receipt of any investigational agents within 30 days prior to commencing study treatment.
- Last dose of prior chemotherapy discontinued less than 4 weeks before the start of study therapy.
- Last radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy.
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 |
|---|---|---|
| Ixabepilone | Drug | Experimental |
| Pemetrexed | Drug | Experimental |
Primary outcome
To determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors.
Time frame: weekly
1 secondary outcome
Response Rate
Time frame: every 42 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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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.
Agustin Garcia, MD principal investigator
Univrsity of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ixabepilone and Pemetrexed in people with Advanced Solid Tumors, run by University of Southern California at 2 sites 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 20 inclusion and 13 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: withdrawn, as of the sponsor's last update on 21 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 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors. (time frame: weekly). 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 21 May 2014; AzTrials last refreshed its copy on 3 Nov 2026.