Ovarian Epithelial Cancer Stage IIIPhase 1/2NCT00316407
Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients
A Phase 1/2 study testing lapatinib (GW572016), Carboplatin and Paclitaxel in people with Ovarian Epithelial Cancer Stage III and Stage IV Ovarian Cancer, run by Swedish Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Epithelial Cancer Stage III, Stage IV Ovarian Cancer, Stage IV Breast Cancer
- What is being tested?
- lapatinib (GW572016), Carboplatin and Paclitaxel
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Nov 2009
- Phase
- Phase 1/2
- 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
- Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.
- Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.
- Ability to swallow and retain oral medications.
- Measurable disease
Who cannot join
- Treatment with previous weekly carboplatin and paclitaxel.
- No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.
- No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
Swedish Medical Center Cancer Institute
Seattle, Washington, 98104
About this study
Official title: Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients
The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.
Read the detailed description
The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.
- Being tested
- lapatinib (GW572016), Carboplatin, Paclitaxel
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinib (GW572016)Drug
Also called Tykerb
1000 mg po qd
CarboplatinDrug
Also called Paraplatin
AUC 2 weekly x 3 of 4 week cycle
PaclitaxelDrug
Also called Taxol
60 mg/m2 weekly x 3 of 4 week cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Measured: 1 year
Secondary outcomes (1)
Objective response (PR or CR)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startAug 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial Cancer Stage IIIStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Saul Rivkin, MD, Principal investigator, Swedish Medical Center Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316407
- Sponsor's protocol ID
- CRC 0503
- Status last verified
- Mar 2010
- First submitted
- 18 Apr 2006
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00316407
- Acronym / sponsor ID
- CRC 0503
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Apr 2006 (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 this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.
Detailed description
The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.
- Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.
- Ability to swallow and retain oral medications.
- Measurable disease
Key exclusion criteria (3 listed)
- Treatment with previous weekly carboplatin and paclitaxel.
- No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.
- No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.
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 |
|---|---|---|
| lapatinib (GW572016)Also: Tykerb1000 mg po qd | Drug | – |
| CarboplatinAlso: ParaplatinAUC 2 weekly x 3 of 4 week cycle | Drug | – |
| PaclitaxelAlso: Taxol60 mg/m2 weekly x 3 of 4 week cycle | Drug | – |
Primary outcome
Toxicity
Time frame: 1 year
1 secondary outcome
Objective response (PR or CR)
Time frame: 1 year
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 18 Feb 2011.
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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.
Saul Rivkin, MD principal investigator
Swedish Medical Center 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 1/2 study testing lapatinib (GW572016), Carboplatin and Paclitaxel in people with Ovarian Epithelial Cancer Stage III and Stage IV Ovarian Cancer, run by Swedish Medical Center 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 4 inclusion and 3 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 18 Feb 2011. 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 combined 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.
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?
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?
Toxicity (time frame: 1 year). 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 18 Feb 2011.