Ovarian CancerPhase 1NCT00317434
Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
A Phase 1 study testing lapatinib in people with Ovarian Cancer, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients. Read more about this study
- Who is it for?
- Ages 19 to 90 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- lapatinib
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to Apr 2007
- 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 19 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of epithelial ovarian or primary peritoneal cancer
- Measurable disease or evaluable disease with CA125 >100
- One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed
- Recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy
- 19 years of age or older
- Life expectancy of greater than 12 weeks
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- Performance status of 0, 1 or 2 (based on GOG Performance Status)
- Normal bone marrow, renal and hepatic function based upon lab tests
- Cardiac ejection fraction within institutional normal range
- Ability to swallow and retain oral medication
- Ability to understand a written informed consent document
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study
- Epithelial ovarian tumors of low malignant potential, stromal or germ cell origin
- Non-measurable or non-evaluable disease
- Archived tumor tissue not available for assay
- Patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines
- Patients with known brain metastases
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Uncontrolled inter-current illness
- Patients who are pregnant
- HIV-positive patients receiving combination anti-retroviral therapy
- Patients with GI tract disease resulting in an inability to take oral medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Indiana University School of Medicine
Indianapolis, Indiana, 48202
About this study
Official title: A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer
The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients.
- Conditions
- Ovarian Cancer
- Being tested
- lapatinib
- Keywords
- ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of Lapatinib measured in cohorts of 3-6 patients each
Secondary outcomes (3)
Clinical response rate defined by RECIST and CA125 values
EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
Correlate serum levels of Lapatinib with AE's & efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startNov 2005
- Primary completionMar 2007
- Study completionApr 2007
Why it stopped: Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Ronald D. Alvarez, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317434
- Sponsor's protocol ID
- UAB 0538 - F051025014
- Other IDs
- 104239
- Status last verified
- Dec 2009
- First submitted
- 20 Apr 2006
- Last updated
- 15 Dec 2009
- Results posted
- No
Publications
Kimball KJ, Numnum TM, Kirby TO, Zamboni WC, Estes JM, Barnes MN, Matei DE, Koch KM, Alvarez RD. A phase I study of lapatinib in combination with carboplatin in women with platinum sensitive recurrent ovarian carcinoma. Gynecol Oncol. 2008 Oct;111(1):95-101. doi: 10.1016/j.ygyno.2008.07.001. Epub 2008 Aug 8.
PubMed 18692224
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00317434
- Acronym / sponsor ID
- UAB 0538 - F051025014
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 24 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 maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologic diagnosis of epithelial ovarian or primary peritoneal cancer
- Measurable disease or evaluable disease with CA125 >100
- One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed
- Recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy
- 19 years of age or older
Key exclusion criteria (11 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study
- Epithelial ovarian tumors of low malignant potential, stromal or germ cell origin
- Non-measurable or non-evaluable disease
- Archived tumor tissue not available for assay
- Patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines
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 | Drug | – |
Primary outcome
MTD of Lapatinib measured in cohorts of 3-6 patients each
3 secondary outcomes
Clinical response rate defined by RECIST and CA125 values
EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
Correlate serum levels of Lapatinib with AE's & efficacy
Results and safety
The study was stopped early (reason given: Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
- Results publication: PubMed 18692224Kimball KJ, Numnum TM, Kirby TO, Zamboni WC, Estes JM, Barnes MN, Matei DE, Koch KM, Alvarez RD. A phase I study of lapatinib in combination with carboplatin in women with platinum sensitive recurrent ovarian carcinoma. Gynecol Oncol. 2008 Oct;111(1):95-101. doi: 10.1016/j.ygyno.2008.07.001. Epub 2008 Aug 8.
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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.
Ronald D. Alvarez, MD principal investigator
University of Alabama at Birmingham
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 lapatinib in people with Ovarian Cancer, run by University of Alabama at Birmingham 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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 Dec 2009. 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 stopped early (reason given: Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.). Results are not available in the source record.
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?
MTD of Lapatinib measured in cohorts of 3-6 patients each. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00317434, which also lists 1 linked publication.
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 Dec 2009.