Lapatinib + Paclitaxel for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose of two drugs, lapatinib (a targeted therapy) and paclitaxel (a chemotherapy drug), for treating ovarian cancer that has not responded to standard platinum-based chemotherapy. Researchers seek to assess the safety of these drugs when used together and identify the best dose for future studies. Candidates may qualify if ovarian cancer returned within a year after platinum chemotherapy and they can manage daily activities with little assistance. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing an opportunity to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not take medications that affect CYP3A4, which is a liver enzyme that processes drugs. If you're on such medications, you may need to stop them, but the protocol doesn't specify a general requirement to stop all current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of lapatinib and paclitaxel appears promising. In one study with 12 patients, two experienced partial tumor shrinkage, and one had stable disease, meaning their tumor did not grow for a while.
Another study found that these drugs helped delay the worsening of a specific type of cancer and improved overall response rates.
While these results are encouraging, they indicate that the treatment remains in early testing stages. Researchers are still studying its safety and patient tolerance. Early-phase trials typically focus on finding the best dose and checking for side effects.
Thus, while some evidence suggests that lapatinib and paclitaxel can work together, the complete safety profile in humans is still being determined. Participants should be aware of this ongoing research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Lapatinib and Paclitaxel for ovarian cancer because it offers a unique approach compared to standard treatments like carboplatin and paclitaxel alone. Lapatinib is a targeted therapy that specifically inhibits certain proteins involved in cancer cell growth, which could enhance the effectiveness of Paclitaxel, a chemotherapy drug. By combining these two, there's potential to improve outcomes by more effectively targeting cancer cells and possibly reducing resistance to treatment. This dual-action approach could provide a new avenue for patients who might not respond as well to existing therapies.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown that using lapatinib and paclitaxel together may help treat ovarian cancer. In one study, about 16% of patients experienced significant tumor shrinkage. Another study found a 44% overall response rate, with some patients experiencing complete tumor disappearance. This trial will test different dosages of lapatinib combined with paclitaxel to evaluate their effectiveness for patients whose cancer does not respond to platinum-based treatments. These early results suggest potential benefits for those with difficult-to-treat ovarian cancer.13456
Who Is on the Research Team?
Frederick R. Ueland
Principal Investigator
Markey Cancer Center
Are You a Good Fit for This Trial?
This trial is for people with ovarian cancer that came back within a year after platinum-based chemo. They should be fairly active (ECOG ≤2), have good organ and bone marrow function, and able to consent. It's not for those allergic to the drugs being tested, with uncontrolled sickness, heart failure, trouble absorbing food, taking certain other meds or any experimental cancer treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dose-escalation of Lapatinib and Paclitaxel to establish the phase II dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lapatinib
- Paclitaxel
Trial Overview
The study tests increasing doses of Lapatinib combined with Paclitaxel in patients whose ovarian cancer resisted platinum chemotherapy. The goal is to find the safest dose level that can be used in future phase II trials.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).
Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).
Lapatinib is already approved in United States, European Union for the following indications:
- Advanced or metastatic breast cancer in combination with capecitabine for patients whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab
- Advanced or metastatic breast cancer in combination with capecitabine for patients whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Frederick R. Ueland, M.D.
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Dose Escalation of Lapatinib With Paclitaxel in Ovarian ...
This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for ...
2.
research.uky.edu
research.uky.edu/news/uk-study-shows-combination-therapy-may-potentially-improve-ovarian-cancer-patient-outcomesUK Study Shows Combination Therapy May Potentially ...
A recent study demonstrates that a combination of two drugs used together provides better than expected results, providing a promising treatment strategy ...
3.
aacrjournals.org
aacrjournals.org/cancerres/article/84/5_Supplement_2/B021/734629/Abstract-B021-A-phase-1-dose-escalation-study-ofAbstract B021: A phase 1 dose escalation study of lapatinib ...
Among the 12 patients evaluable for efficacy, there were two partial responses and one stable disease for an objective response rate of 16% and ...
Ovarian cancer targeted therapy: current landscape and future ...
Over 80% of newly diagnosed patients achieve partial or complete remission after initial treatment; however, most experience relapse within three years, and ...
A Phase I/II Study of Lapatinib Plus Carboplatin and ...
The overall response rate of the 25 evaluable patients was 44%, with 4 (16%) complete responses and 7 (28%) partial responses. Nine patients achieved stable ...
Phase III, Double-Blind, Randomized Study Comparing ...
In 86 HER-2–positive patients (15%), treatment with paclitaxel-lapatinib resulted in statistically significant improvements in TTP, EFS, ORR, and CBR compared ...
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