Lurbinectedin + Paclitaxel + Bevacizumab for Ovarian Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: M.D. Anderson Cancer Center
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.
How is the drug combination of Lurbinectedin, Paclitaxel, and Bevacizumab unique for ovarian cancer?
This drug combination is unique because it includes Lurbinectedin, which is not commonly used in standard ovarian cancer treatments. Lurbinectedin works by interfering with the cancer cell's DNA, while Bevacizumab targets blood vessels that supply the tumor, and Paclitaxel stops cancer cells from dividing, offering a multi-faceted approach to treatment.
145810Is the combination of Lurbinectedin, Paclitaxel, and Bevacizumab safe for humans?
Research shows that the combination of Bevacizumab and Paclitaxel has been studied for safety in treating ovarian cancer, with Bevacizumab being used in various chemotherapy regimens. These studies suggest that the combination is generally safe, although specific side effects and risks should be discussed with a healthcare provider.
367810Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received anti-cancer treatment within 2 weeks before starting the trial, and there must be at least 10 days between stopping any prior treatment and starting the study treatment.
What data supports the effectiveness of the drug combination Lurbinectedin, Paclitaxel, and Bevacizumab for ovarian cancer?
Research shows that combining bevacizumab with paclitaxel and other drugs can improve progression-free survival (the time during and after treatment that a patient lives with the disease without it getting worse) in ovarian cancer patients. Bevacizumab has been effective in managing ovarian cancer, especially when used with other chemotherapy drugs.
2891112Eligibility Criteria
This trial is for adults with ovarian, fallopian tube, or peritoneal carcinoma that's resistant to platinum-based treatments. Participants must be in good physical condition (ECOG 0-1), have had any number of prior therapies but no recent anti-cancer treatments, and not be pregnant or breastfeeding. They should not have serious heart issues, uncontrolled infections, significant bleeding disorders, or known allergies to the drugs being tested.Participant Groups
The study tests if adding lurbinectedin to paclitaxel and bevacizumab can better control advanced ovarian cancer. It's a Phase 1b trial which means it’s early in testing this combination treatment and focuses on safety and how well patients tolerate the drug mix.
1Treatment groups
Experimental Treatment
Group I: Dose Escalation and Dose ExpansionExperimental Treatment3 Interventions
Pariticipants will be assigned to a dose level of combined paclitaxel, bevacizumab, and lurbinectedin
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
🇪🇺 Approved in European Union as Avastin for:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
🇺🇸 Approved in United States as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
🇯🇵 Approved in Japan as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
🇨🇦 Approved in Canada as Avastin for:
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
Jazz PharmaceuticalsIndustry Sponsor
References
Sustained progression-free survival with weekly paclitaxel and bevacizumab in recurrent ovarian cancer. [2015]To determine efficacy, toxicity, and survival in patients with recurrent epithelial ovarian cancer (EOC) receiving combination of weekly paclitaxel and biweekly bevacizumab (PB).
The use of bevacizumab in the management of ovarian cancer: an argument for single-agent rather than combination therapy. [2020]Bevacizumab is a biologically and clinically active antineoplastic agent in the management of epithelial ovarian cancer. While phase III trial data have revealed the favorable impact on progression-free survival associated with combining the agent with cytotoxic chemotherapy, at the current time a strong argument can be made (based on both efficacy and cost-effectiveness considerations) that a more rational approach to utilizing bevacizumab in ovarian cancer would be to administer the drug as a single agent in the platinum-resistant setting.
A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy. [2021]The efficacy and safety of bevacizumab and docetaxel were evaluated in women who developed recurrent epithelial ovarian, fallopian, or peritoneal cancer within 12 months of platinum-based therapy.
Bevacizumab combination therapy: a review of its use in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. [2019]Bevacizumab (Avastin®) is a recombinant, humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody that neutralizes the biological activity of VEGF and inhibits tumor angiogenesis. In the EU, in adult patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, bevacizumab (in combination with carboplatin and paclitaxel) is approved for the first-line treatment of advanced disease and (in combination with carboplatin and gemcitabine) is approved for the treatment of patients with first recurrence of platinum-sensitive disease who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. This article summarizes the pharmacology of bevacizumab and reviews the efficacy and tolerability of bevacizumab combination therapy in well-designed clinical studies in these indications. The addition of bevacizumab to first-line carboplatin plus paclitaxel, followed by bevacizumab maintenance therapy significantly prolonged progression-free survival in women with newly-diagnosed advanced disease (GOG-0218 and ICON7 studies). Progression-free survival was also significantly prolonged after second-line treatment with bevacizumab in combination with carboplatin and gemcitabine, followed by maintenance treatment with bevacizumab alone in women with recurrence (≥ 6 months after front-line platinum-based therapy) of platinum-sensitive disease (OCEANS study). Bevacizumab combination therapy had a generally acceptable tolerability profile in these studies, with the nature of adverse events generally similar to that observed in previous clinical trials in patients with other solid tumors. Although several unanswered questions remain, such as the optimal dosage and duration of treatment, current evidence suggests that bevacizumab combination therapy extends the treatment options available for patients with ovarian cancer.
Bevacizumab, Carboplatin and Paclitaxel Combination Treatment in Advanced Stage Ovarian Cancer: The First Experience in Thammasat University Hospital, Thailand: A Case Report. [2018]Bevacizumab, a humanized monoclonal antibody targeting vascular endothelial growthfactor (VEGF), has been approvedfor concurrent treatment with first line chemotherapy in advanced epithelial ovarian cancer.
Bevacizumab plus paclitaxel versus bevacizumab plus capecitabine as first-line treatment for HER2-negative metastatic breast cancer (TURANDOT): primary endpoint results of a randomised, open-label, non-inferiority, phase 3 trial. [2022]The randomised phase 3 TURANDOT trial compared two approved bevacizumab-containing regimens for HER2-negative metastatic breast cancer in terms of efficacy, safety, and quality of life. The interim analysis did not confirm non-inferior overall survival (stratified hazard ratio [HR] 1·04; 97·5% repeated CI [RCI] -∞ to 1·69). Here we report final results of our study aiming to show non-inferior overall survival with first-line bevacizumab plus capecitabine versus bevacizumab plus paclitaxel for locally recurrent or metastatic breast cancer.
New Therapies for Ovarian Cancer. [2020]After 3 to 4 decades of stagnation, several new options are available for the treatment of ovarian cancer, some of which produce longer survival compared with historical controls. Additionally, 3 new PARP inhibitors (olaparib, rucaparib, niraparib) have been approved for use in ovarian cancer, with different indications as maintenance therapy or treatment of recurrence. Indications for bevacizumab have been extended, and there are now multiple combination chemotherapy regimens that include bevacizumab as part of initial treatment and as an option for maintenance therapy in select patients, both for first-line primary/adjuvant chemotherapy and for treatment of recurrent or refractory disease.
Therapeutic effect of bevacizumab combined with paclitaxel and carboplatin on recurrent ovarian cancer. [2020]To observe the clinical efficacy and safety of bevacizumab (BEV) combined with paclitaxel on recurrent ovarian cancer.
Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. [2020]Label="BACKGROUND">Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown.
Efficacy of Bevacizumab Combined with Albumin-Bound Paclitaxel in the Treatment of Platinum-Resistant Recurrent Ovarian Cancer. [2020]To investigate the efficacy and safety of bevacizumab (BEV) combined with albumin-bound paclitaxel (ABP) in the treatment of platinum-resistant recurrent ovarian cancer.
Effect of bevacizumab plus paclitaxel and carboplatin regimen on prognostic survival of ovarian cancer patients. [2023]To investigate the efficacy of bevacizumab, paclitaxel and carboplatin in the treatment of ovarian cancer (OC) and the impact on patients' prognosis.
Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. [2023]In the PAOLA-1/ENGOT-ov25 primary analysis, maintenance olaparib plus bevacizumab demonstrated a significant progression-free survival (PFS) benefit in newly diagnosed advanced ovarian cancer patients in clinical response after first-line platinum-based chemotherapy plus bevacizumab, irrespective of surgical status. Prespecified, exploratory analyses by molecular biomarker status showed substantial benefit in patients with a BRCA1/BRCA2 mutation (BRCAm) or homologous recombination deficiency (HRD; BRCAm and/or genomic instability). We report the prespecified final overall survival (OS) analysis, including analyses by HRD status.