Ipatasertib + Chemotherapy for Ovarian Cancer
Recruiting in Palo Alto (17 mi)
+9 other locations
Overseen byKatherine C Fuh
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Trial Summary
What is the purpose of this trial?This phase I/IB trial tests the safety, side effects, and best dose of ipatasertib in combination with paclitaxel and carboplatin in treating patients with stage III or IV epithelial ovarian cancer. Ipatasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving ipatasertib in combination with paclitaxel and carboplatin may lower the chance of the tumor growing or spreading for longer than the paclitaxel and carboplatin alone.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot take strong CYP3A inhibitors or inducers within 2 weeks before joining the trial. It's important to discuss your current medications with the trial team to avoid any potential interactions.
What data supports the idea that Ipatasertib + Chemotherapy for Ovarian Cancer is an effective treatment?
The available research shows that combining paclitaxel and carboplatin is a standard and effective treatment for ovarian cancer. It is noted for being highly active in patients with platinum-resistant ovarian cancer. Studies have shown that this combination is at least as effective as other similar treatments and is better tolerated, meaning patients experience fewer side effects. While the specific combination of Ipatasertib with chemotherapy isn't directly mentioned, the effectiveness of paclitaxel and carboplatin suggests that adding Ipatasertib could potentially enhance treatment outcomes.
12345What safety data exists for the treatment of ovarian cancer with Ipatasertib and chemotherapy?
The safety data for chemotherapy involving carboplatin and paclitaxel in ovarian cancer treatment is well-documented. Studies have evaluated the tolerability, toxicity, and activity of these drugs in various combinations. Paclitaxel, in combination with platinum compounds like carboplatin, is a standard treatment for advanced ovarian cancer. Research has focused on dose intensity, administration schedules, and hypersensitivity reactions. However, specific safety data for the combination of Ipatasertib with these chemotherapy agents is not detailed in the provided research.
13678Is the drug combination of Carboplatin, Ipatasertib, and Paclitaxel promising for ovarian cancer?
Yes, the combination of Carboplatin and Paclitaxel is already a standard and effective treatment for ovarian cancer, especially in advanced cases. Adding Ipatasertib, which is a new drug, could potentially make the treatment even more effective by targeting cancer cells in a different way.
1291011Eligibility Criteria
This trial is for women aged 18+ with stage III or IV epithelial ovarian cancer that's inoperable and hasn't been treated yet. Participants must have good performance status, meet specific blood count and organ function criteria, not be pregnant or breastfeeding, agree to use two forms of birth control, and can't have had prior treatments targeting the PI3K/AKT/mTor pathway.Inclusion Criteria
I have a history of heart issues or have been treated with heart-toxic drugs.
My condition requires chemotherapy before surgery to remove my tumor.
I have chronic hepatitis B but it's undetectable with my current treatment.
+16 more
Exclusion Criteria
I am currently on IV antibiotics for an infection.
I haven't taken strong CYP3A affecting drugs recently.
I have had radiation therapy to my abdomen or pelvis before.
+13 more
Participant Groups
The study tests the safety and optimal dose of ipatasertib combined with standard chemotherapy drugs paclitaxel and carboplatin. Ipatasertib may block enzymes needed for tumor growth while the chemo drugs aim to stop or slow down tumor cell division, potentially improving treatment outcomes.
1Treatment groups
Experimental Treatment
Group I: Treatment (paclitaxel, carboplatin, ipatasertib)Experimental Treatment4 Interventions
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ipatasertib PO QD until 24 hours before surgery in the absence of disease progression or unacceptable toxicity.
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NRG OncologyPhiladelphia, PA
Thomas Jefferson University HospitalPhiladelphia, PA
UCSF Medical Center-Mission BaySan Francisco, CA
Augusta University Medical CenterAugusta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)Lead Sponsor
NRG OncologyCollaborator
References
Treatment of ovarian cancer: current status. [2015]Cytoreductive surgery followed by platinum-based combination chemotherapy has been standard therapy for patients with advanced epithelial ovarian cancer. Despite advances in surgery and in the development of a less toxic platinum compound (carboplatin), most patients with advanced ovarian cancer are not cured. Current clinical trials focus on dose-intense chemotherapy, routes and schedules of administration, and the role of paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ). This novel agent has been shown to be highly active in patients with platinum-resistant ovarian cancer. Paclitaxel together with platinum (ie, cisplatin or carboplatin) combinations are now being tested in prospective randomized trials and in pilot studies in previously untreated patients with advanced disease.
Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: long-term efficacy results: a Hellenic Cooperative Oncology Group (HeCOG) study. [2022]We compared the combination plus Carboplatin plus paclitaxel, which is considered the treatment of choice for initial chemotherapy of advanced ovarian cancer (AOC) with a regimen combining alternating carboplatin and cisplatin plus paclitaxel. The two platinum derivatives have been previously combined as they are not totally cross-resistant and as they share no overlapping toxicities.
A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8). [2022]A multicenter, nonrandomized, phase II study was initiated to evaluate the tolerability, toxicity, and activity of paclitaxel, carboplatin, and gemcitabine combination in previously untreated ovarian cancer.
Outpatient taxol and carboplatin chemotherapy for suboptimally debulked epithelial carcinoma of the ovary results in improved quality of life: an Eastern Cooperative Oncology Group Phase II Study (E2E93). [2015]The combination of a platinum compound and paclitaxel is a standard treatment for ovarian cancer. In this cooperative group trial, paclitaxel and carboplatin were combined in an outpatient schedule to determine the clinical benefit, toxicities, and effect on quality of life.
Advanced ovarian cancer: a clinical update on first-line treatment, recurrent disease, and new agents. [2022]Platinum-based therapy plays an integral role in the first-line treatment of advanced ovarian cancer as well as in the recurrent disease setting. In advanced disease, the standard of care in the United States is maximal surgical cytoreduction followed by paclitaxel/carboplatin chemotherapy. Results from the Gynecologic Oncology Group COG 158 trial show that paclitaxel/carboplatin is at least as effective as paclitaxel/cisplatin and is better tolerated and easier to administer. Three randomized phase III trials suggest that intraperitoneal chemotherapy may provide superior progression-free or overall survival relative to systemic chemotherapy, but at the price of increased toxicity. Results from COG 178 showed that prolonged maintenance paclitaxel therapy improved progression-free survival of patients with clinical complete responses to first-line chemotherapy. The ongoing COG 182 protocol for advanced ovarian cancer is comparing 8 cycles of paclitaxel/carboplatin with 4 experimental combinations incorporating topotecan, gemcitabine, or encapsulated doxorubicin. Currently, no randomized GOG trial evaluates maintenance or intraperitoneal therapy for advanced disease. With recurrent disease, a treatment-free interval of more than 6 months is an important predictor of platinum sensitivity. In this setting, carboplatin has been the cornerstone of treatment. Recent results from the International Collaborative Ovarian Neoplasm ICON 4 trial indicate that paclitaxel/carboplatin may offer superior efficacy to single-agent carboplatin. Additional randomized comparisons of carboplatin versus other carboplatin combinations are in progress. Finally, a variety of new cytotoxic and biologic agents are being evaluated in recurrent disease, either as single agents or in combination with standard chemotherapy.
Safety and Efficacy of Weekly Paclitaxel and Cisplatin Chemotherapy for Ovarian Cancer Patients with Hypersensitivity to Carboplatin. [2021]This study aimed to evaluate the safety and efficacy of weekly paclitaxel and cisplatin chemotherapy (wTP) in patients with ovarian cancer who developed carboplatin hypersensitivity reaction (HSR).
USA update on paclitaxel in ovarian cancer. [2019]In the United States, the role of paclitaxel in the treatment of advanced ovarian cancer has expanded markedly in the last 2 years. The drug was initially approved by the Food and Drug Administration for refractory ovarian cancer. However, on the basis of a large prospective randomized trial by the Gynaecologic Oncology Group, paclitaxel together with a platinum compound has now become accepted as a standard form of chemotherapy for previously untreated patients with ovarian cancer. There still remain many unanswered questions as how to best utilize paclitaxel together with platinum compounds. Clinical trials are currently in progress evaluating the dose intensity of paclitaxel, the effect of schedule of administration, and the relative efficacy and toxicity of paclitaxel plus carboplatin vs. paclitaxel plus cisplatin.
Carboplatin and short-infusion paclitaxel in high-risk and advanced-stage ovarian carcinoma. [2015]To present tolerance and toxicity information on previously untreated high-risk early-stage and advanced-stage primary epithelial ovarian cancer patients treated with adjuvant 3-hour paclitaxel and carboplatin.
A phase 2 study of intraperitoneal carboplatin plus intravenous dose-dense paclitaxel in front-line treatment of suboptimal residual ovarian cancer. [2021]We evaluated the efficacy of intraperitoneal (IP) carboplatin in combination with dose-dense paclitaxel (ddTCip) for suboptimal residual ovarian cancer.
[Clinical study on the efficacy of weekly paclitaxel administration for platinum-resistant epithelial ovarian carcinoma]. [2015]Recently, paclitaxel (T) and carboplatin (J) combination chemotherapy has been a standard first-line chemotherapy for epithelial ovarian cancer and has improved its prognosis. But we have many chemoresistant cases, and we examined the efficacy of weekly, single-agent, paclitaxel administration.
New and emerging intraperitoneal (IP) drugs for ovarian cancer treatment. [2007]Chemotherapy after surgical debulking represents an essential component of treatment for patients with advanced ovarian cancer. Three quarters of patients respond very well to initial treatment with platinum-containing drugs used either alone or in combination with a taxane, usually paclitaxel. With relapse rates exceeding 50% and median survival time of 2 years for patients after relapse, efforts are focused on treatment approaches to achieve and extend clinical complete remissions. These approaches include consolidation and maintenance therapy, intraperitoneal (IP) administration of cytotoxic agents, new combination chemotherapy regimens, development of new cytotoxic agents, and molecular-targeted therapies (beyond tumor DNA, the classical target of cytotoxic drugs). IP chemotherapy, which involves direct instillation of chemotherapy into the tumor site in the peritoneal cavity, is the focus of this review article. This article discusses studies involving new and emerging IP drugs for both first-line chemotherapy treatment of advanced ovarian cancer and recurrent platinum-sensitive ovarian cancer.