Advanced Colorectal CancerPhase 1NCT00598247
A Pilot Study of PPX in Women With Metastatic Colorectal Cancer
A Phase 1 study testing Paclitaxel Poliglumex in people with Advanced Colorectal Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This study uses the drug PPX (also called Xyotax and CT-2103) in women with advanced colorectal cancer. PPX is an experimental drug that has not been approved by the Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Paclitaxel Poliglumex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically confirmed metastatic adenocarcinoma of the colon or rectum. The primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites.
- Must have failed or are intolerant of or ineligible for CPT-11, 5-FU, oxaliplatin, bevacizumab and either cetuximab or panitumumab therapies.
- Tumor must be accessible for biopsy or paraffin embedded tissue must be available for review.
- SWOG performance status 0-2.
- Estradiol levels >30 pg/mL **This may be supplemented by exogenous estrogen (by gel)
- AGC >1,500, platelets >100,000
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- Total bilirubin < 3 x upper limit of normal, Transaminase (AST and/or ALT) < 2 x upper limit of normal or < 5 x upper limit of normal in patients with liver metastasis.
- Patients must have a creatinine of < 1.5 x upper limit of normal or a measured or calculated creatinine clearance greater than 35 mL/min obtained within 7 days of first receiving study drug.
- Except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.
- At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > 10 mm measured by spiral CT or > 20mm measured by conventional techniques.
- Have a negative serum pregnancy test within 7 days prior to initiation of chemotherapy (female patients of childbearing potential).
- Life expectancy > 3 months.
Who cannot join
- History of a malignancy other than colon or rectal cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
- Estradiol levels < 30 pg/mL, not responsive to supplementation.
- History of previous thromboembolic event, unless patient is on anticoagulation therapy.
- Grade 2 or greater neuropathy.
- Pregnant or lactating woman. Woman or men of childbearing potential not using a reliable and appropriate contraceptive method (either a barrier or hormonal method is acceptable). Patients must agree to continue contraception for 30 days from the date of the last study drug administration. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Patients with known brain metastases, unless they are well controlled - i.e. on a stable dose of steroids or if steroid therapy has been completed.
- Patients that have received experimental therapies or other approved bio- or chemotherapies within 30 days of study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) in Women With Metastatic Colorectal Cancer
This study uses the drug PPX (also called Xyotax and CT-2103) in women with advanced colorectal cancer. PPX is an experimental drug that has not been approved by the Food and Drug Administration (FDA). PPX has been shown in the laboratory and in studies in humans to cause some cancer cells to die and some tumors to shrink. Women in some studies with PPX have been shown to live longer than the men that receive the drug. Some studies in humans suggest that estrogen (a hormone found in women) may protect women from getting colorectal cancer and allow women that do get colorectal cancer to live longer than men that do.
The purpose of this study is to see if women with colorectal cancer and a certain level of estrogen experience tumor shrinkage after they receive the drug PPX. This study will also study genes (genes are the cell's blueprint) in participant's tumors and in their blood. Several genes can affect how people's bodies react to the cancer drugs. We want to see if these predict response to the study drugs.
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Paclitaxel Poliglumex
- Keywords
- Colon Cancer Rectal Colorectal Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel PoliglumexDrug
Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Paclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks. A Receives: Drug: Paclitaxel Poliglumex |
What is being measured
The primary outcome is the main question the study is designed to answer.
RECIST Response
Measured: Assessed Every 6 Weeks Until Patient goes off Study
Secondary outcomes (2)
Time to progression
Measured: Until Patient goes off study
Toxicity
Measured: Until Patient Goes off study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- CTI BioPharma, ASCEND Therapeutics
- Responsible party
- Sponsor
- Investigators
- Syma Iqbal, M.D., Principal investigator, U.S.C. / Norris Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598247
- Sponsor's protocol ID
- 3C-07-3
- Status last verified
- Feb 2014
- First submitted
- 10 Jan 2008
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) in Women With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00598247
- Acronym / sponsor ID
- 3C-07-3
- Conditions
- Advanced Colorectal Cancer
- Keywords
- Colon Cancer Rectal Colorectal Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- CTI BioPharma, ASCEND Therapeutics
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Jan 2008 (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.
This study uses the drug PPX (also called Xyotax and CT-2103) in women with advanced colorectal cancer. PPX is an experimental drug that has not been approved by the Food and Drug Administration (FDA). PPX has been shown in the laboratory and in studies in humans to cause some cancer cells to die and some tumors to shrink. Women in some studies with PPX have been shown to live longer than the men that receive the drug. Some studies in humans suggest that estrogen (a hormone found in women) may protect women from getting colorectal cancer and allow women that do get colorectal cancer to live longer than men that do.
The purpose of this study is to see if women with colorectal cancer and a certain level of estrogen experience tumor shrinkage after they receive the drug PPX. This study will also study genes (genes are the cell's blueprint) in participant's tumors and in their blood. Several genes can affect how people's bodies react to the cancer drugs. We want to see if these predict response to the study drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Paclitaxel PoliglumexPaclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks. A |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women with histologically confirmed metastatic adenocarcinoma of the colon or rectum. The primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites.
- Must have failed or are intolerant of or ineligible for CPT-11, 5-FU, oxaliplatin, bevacizumab and either cetuximab or panitumumab therapies.
- Tumor must be accessible for biopsy or paraffin embedded tissue must be available for review.
- SWOG performance status 0-2.
- Estradiol levels >30 pg/mL **This may be supplemented by exogenous estrogen (by gel)
Key exclusion criteria (7 listed)
- History of a malignancy other than colon or rectal cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
- Estradiol levels < 30 pg/mL, not responsive to supplementation.
- History of previous thromboembolic event, unless patient is on anticoagulation therapy.
- Grade 2 or greater neuropathy.
- Pregnant or lactating woman. Woman or men of childbearing potential not using a reliable and appropriate contraceptive method (either a barrier or hormonal method is acceptable). Patients must agree to continue contraception for 30 days from the date of the last study drug administration. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
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 PoliglumexPaclitaxel Poliglumex 175 mg/m2 will be given over ten minutes every 3 weeks. | Drug | A |
Primary outcome
RECIST Response
Time frame: Assessed Every 6 Weeks Until Patient goes off Study
2 secondary outcomes
Time to progression
Time frame: Until Patient goes off study
Toxicity
Time frame: Until Patient Goes off study
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 6 Feb 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.
Syma Iqbal, M.D. principal investigator
U.S.C. / Norris Comprehensive 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 1 study testing Paclitaxel Poliglumex in people with Advanced Colorectal Cancer, run by University of Southern California 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 12 inclusion and 7 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 6 Feb 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 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.
What does the primary outcome measure?
RECIST Response (time frame: Assessed Every 6 Weeks Until Patient goes off Study). 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 6 Feb 2014.