What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as Carboplatin, often cause side effects including nausea, vomiting, fatigue, and myelosuppression (reduced blood cell counts). When combined with agents like paclitaxel, additional side effects can include peripheral neuropathy (nerve damage) and hair loss. Bevacizumab, an angiogenesis inhibitor, can lead to hypertension, proteinuria (protein in urine), and increased risk of bleeding or thromboembolic events. Pegylated liposomal doxorubicin is associated with hand-foot syndrome (redness and swelling of palms and soles) and mucositis (inflammation of the mucous membranes). Novel agents like CPI-0209, while still under investigation, may have unique side effects related to their specific mechanisms of action, but these are not yet fully characterized.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer that involve novel agents used in combination with Carboplatin and as maintenance therapy. Notably, PARP inhibitors such as Olaparib, Niraparib, and Rucaparib have been approved for maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer following a response to platinum-based chemotherapy. Bevacizumab, an angiogenesis inhibitor, has also been approved in combination with Carboplatin and Paclitaxel for the treatment of advanced ovarian cancer and as maintenance therapy. These approvals highlight the trend of combining novel targeted therapies with traditional chemotherapy to enhance treatment efficacy and prolong progression-free survival.

What other types of research exist?

Promising novel alternatives to CPI-0209 for ovarian cancer patients include: <ol> <li>ZD9331: A direct-acting thymidylate synthase inhibitor, evaluated in heavily pretreated ovarian cancer patients.</li> <li></li> </ol> Temsirolimus: An mTOR inhibitor, showing promise in combination with bevacizumab for recurrent or metastatic endometrial cancer, which may have potential in ovarian cancer. 3. Everolimus: Another mTOR inhibitor, combined with letrozole, showing a clinical benefit rate in recurrent endometrial cancer. 4. Oxaliplatin: Evaluated as a single-agent in cisplatin/carboplatin-pretreated ovarian cancer patients. 5. Cetuximab: Combined with carboplatin in relapsed platinum-sensitive ovarian cancer, targeting the epidermal growth factor receptor.

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Alkylating agents

CPI-0209 + Carboplatin for Ovarian Cancer

Phase 1

Recruiting

Led By Lan Coffman, MD, PhD

Research Sponsored by Lan Coffman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treated CNS metastasis allowed if treatment is completed ≥8 weeks prior to enrollment. Patients must be asymptomatic off systemic corticosteroids for at least 4 weeks after completion of radiation therapy. CNS disease must be stable or regressed on repeat imaging performed at least 4 weeks after completion of therapy

In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment

Must not have

Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects

Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, CPI-0209, combined with chemotherapy in patients with recurrent ovarian cancer. The goal is to see if CPI-0209 can make chemotherapy work better and prevent the cancer from returning by blocking resistance and spread.

Who is the study for?

This trial is for women with ovarian cancer that has returned more than 6 months after platinum-based chemotherapy. They must be able to take oral medication, have a life expectancy of at least 3 months, and agree to use effective contraception. Exclusions include certain medical conditions, recent treatments or surgeries, and those not recovered from previous therapy side effects.

What is being tested?

The study tests CPI-0209 combined with Carboplatin followed by maintenance CPI-0209 in patients with recurrent ovarian cancer who responded well previously to platinum-based treatment. The goal is to see if this combination helps control the cancer better than current treatments.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to CPI-0209, typical chemotherapy-related issues like nausea and fatigue from Carboplatin, as well as possible impacts on blood counts and organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had brain metastasis treated over 8 weeks ago, am off steroids for 4 weeks, and my condition is stable or improved.

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I have been on the same birth control pill for at least 3 months.

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I can care for myself and my doctor expects me to live at least 3 more months.

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I can swallow pills or liquid medicine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery in the last 2 weeks or still have major side effects from it.

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I had radiotherapy recently and still experience side effects.

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I have a history of HIV infection.

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My cancer is considered to be of low aggressiveness.

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I have severe nerve damage.

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My liver disease is moderately to severely advanced.

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I am currently taking warfarin or a similar blood thinner.

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I do not have any severe health conditions that would make it unsafe for me to join the study.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) of CPI-0209

Secondary study objectives

Adverse Events by Grade per CTCAE v5.0

Overall Response Rate (ORR)

Progression-free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: CPI-0209 (250 mg) + carboplatinExperimental Treatment2 Interventions

CPI-0209: 250 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Group II: CPI-0209 (200 mg) + carboplatinExperimental Treatment2 Interventions

CPI-0209: 200 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Group III: CPI-0209 (150 mg) + carboplatinExperimental Treatment2 Interventions

CPI-0209: 150 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

carboplatin

2010

Completed Phase 3

~4790

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian cancer include platinum-based chemotherapies like carboplatin, which induce DNA damage in cancer cells, and taxanes like paclitaxel, which disrupt cell division by stabilizing microtubules. PARP inhibitors, another class of treatment, target cancer cells with defective DNA repair mechanisms, particularly those with BRCA mutations, leading to cell death. Targeted therapies, such as CPI-0209, often inhibit specific pathways critical for cancer cell survival and proliferation. These treatments are crucial for ovarian cancer patients as they exploit the unique vulnerabilities of cancer cells, improving treatment efficacy and patient outcomes. The combination of CPI-0209 with carboplatin, as studied in clinical trials, aims to enhance the effectiveness of chemotherapy and provide sustained control of the disease through maintenance therapy.

Adjunct Histamine Blockers as Premedications to Prevent Carboplatin Hypersensitivity Reactions.Pharmaceutical management of ovarian cancer : current status.Intraperitoneal carboplatin-based chemotherapy for epithelial ovarian cancer.