Ovarian CancerPhase 1NCT00268918
Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
A Phase 1 study testing Docetaxel and PTK787 in people with Ovarian Cancer and Endometrial Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer
- What is being tested?
- Docetaxel and PTK787
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2005to Jan 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
- Recurrent gynecological cancers or metastatic breast cancer. Initial diagnosis must be confirmed histologically.
- Measurable disease or nonmeasurable disease
- Age > 18 years
- ECOG performance 0,1,2
- 4 weeks or greater since major surgery, 3 weeks or greater since chemotherapy
- Certain lab values
- Negative for proteinuria
Who cannot join
- Four or more treatment regimens
- History or presence of uncontrolled CNS disease
- Prior biologic or immunotherapies less than 3 weeks prior to registration
- Prior full field radiotherapy less than 4 weeks or limited field radiotherapy less than 2 weeks prior to registration
- Prior therapy with anti-VEGF agents
- Peripheral neuropathy with functional impairment > CTC grade 2
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- Pregnant or breast feeding
- Concurrent severe and/or uncontrolled medical condition
- Chronic renal disease
- Acute or chronic liver disease
- Impairment of gastrointestinal function or GI disease
- Confirmed diagnosis of HIV infection are excluded at the investigators discretion
- Therapeutic warfarin sodium or similar oral anticoagulants that are metabolized by the cytochrome p450 system.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
The main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects.
Read the detailed description
- Patients will come to the clinic once a week to receive study treatment. To help reduce the chance of an allergic reaction patients will take Decadron tablets orally the night before, the morning of and the evening of receiving chemotherapy.
- The lead-in schedule of dosing is as follows: Day 1: Taxotere intravenously; Day 4: PTK787 orally; Day 14: Taxotere and PTK787.
- After the lead-in schedule, a cycle will consist of 28 days. PTK787 will be given orally once a day without interruption. Taxotere will be given on Day 1, Day 8, Day 15 and Day 22.
- Before each dose of Taxotere, blood tests, urine tests, and a physical exam will be done. A radiological evaluation will be done every two months. If the patients tumor remains stable or shrinks in size, they may continue to stay on the study.
- Patients should not eat grapefruit or drink grapefruit juice during this study.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer
- Being tested
- Docetaxel, PTK787
- Keywords
- PTK787, Metastatic breast cancer, Refractory gynecological cancer
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Fallopian Tube Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Participants may continue receiving study drug as long as their disease does not worsen
PTK787Drug
Also called Vatalanib
Participants may continue receiving study drug as long as their disease does not worsen
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel / PTK787 | Experimental | Docetaxel: Lead In: Given intravenously on Day 1 and Day 14 Afer Lead in: Given intravenously on day 1, 8, 15, 22 of each 28-day cycle.
PTK787: Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day. Receives: Drug: Docetaxel; Drug: PTK787 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
Measured: 2 years
Secondary outcomes (1)
To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2007
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Susana M. Campos, MD, Dana-Farber Cancer Institute
- Investigators
- Susana M. Campos, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268918
- Sponsor's protocol ID
- 05-020
- Status last verified
- Jul 2018
- First submitted
- 21 Dec 2005
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
- ClinicalTrials.gov ID
- NCT00268918
- Acronym / sponsor ID
- 05-020
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer
- Keywords
- PTK787, Metastatic breast cancer, Refractory gynecological cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Sep 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Dec 2005 (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 main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects.
Detailed description
- Patients will come to the clinic once a week to receive study treatment. To help reduce the chance of an allergic reaction patients will take Decadron tablets orally the night before, the morning of and the evening of receiving chemotherapy.
- The lead-in schedule of dosing is as follows: Day 1: Taxotere intravenously; Day 4: PTK787 orally; Day 14: Taxotere and PTK787.
- After the lead-in schedule, a cycle will consist of 28 days. PTK787 will be given orally once a day without interruption. Taxotere will be given on Day 1, Day 8, Day 15 and Day 22.
- Before each dose of Taxotere, blood tests, urine tests, and a physical exam will be done. A radiological evaluation will be done every two months. If the patients tumor remains stable or shrinks in size, they may continue to stay on the study.
- Patients should not eat grapefruit or drink grapefruit juice during 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 |
|---|---|---|
| Docetaxel / PTK787 | Experimental | Drug: Docetaxel, Drug: PTK787Docetaxel: Lead In: Given intravenously on Day 1 and Day 14 Afer Lead in: Given intravenously on day 1, 8, 15, 22 of each 28-day cycle. PTK787: Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Recurrent gynecological cancers or metastatic breast cancer. Initial diagnosis must be confirmed histologically.
- Measurable disease or nonmeasurable disease
- Age > 18 years
- ECOG performance 0,1,2
- 4 weeks or greater since major surgery, 3 weeks or greater since chemotherapy
Key exclusion criteria (13 listed)
- Four or more treatment regimens
- History or presence of uncontrolled CNS disease
- Prior biologic or immunotherapies less than 3 weeks prior to registration
- Prior full field radiotherapy less than 4 weeks or limited field radiotherapy less than 2 weeks prior to registration
- Prior therapy with anti-VEGF agents
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 |
|---|---|---|
| DocetaxelAlso: TaxotereParticipants may continue receiving study drug as long as their disease does not worsen | Drug | Docetaxel / PTK787 |
| PTK787Also: VatalanibParticipants may continue receiving study drug as long as their disease does not worsen | Drug | Docetaxel / PTK787 |
Primary outcome
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
Time frame: 2 years
1 secondary outcome
To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.
Time frame: 2 years
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 27 Jul 2018.
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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.
Susana M. Campos, MD principal investigator
Dana-Farber Cancer Institute
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 Docetaxel and PTK787 in people with Ovarian Cancer and Endometrial Cancer, run by Dana-Farber Cancer Institute 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 7 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: finished, as of the sponsor's last update on 27 Jul 2018. 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 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?
To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787. (time frame: 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 27 Jul 2018.