What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, including Hyperthermic Intraperitoneal Chemotherapy (HIPEC), can cause a range of side effects. General chemotherapy side effects include nausea, vomiting, hair loss, fatigue, and increased infection risk. HIPEC, which involves heated chemotherapy directly applied to the abdominal cavity, can additionally cause abdominal pain, infection, bowel obstruction, and surgical complications. These side effects stem from the invasive procedure and the high drug concentrations used.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer, including platinum-based chemotherapies such as carboplatin and cisplatin, which are often used in combination with other agents like paclitaxel. Bevacizumab, an angiogenesis inhibitor, has also been approved for use in combination with chemotherapy for ovarian cancer. While HIPEC itself is not specifically FDA-approved, it involves the use of these approved chemotherapeutic agents administered in a heated, intraperitoneal manner to enhance their efficacy against residual cancer cells.

What other types of research exist?

Promising novel alternatives to HIPEC for ovarian cancer patients include: 1) PARP inhibitors (e.g., olaparib, niraparib) for patients with BRCA mutations or homologous recombination deficiency, 2) Anti-angiogenesis agents (e.g., bevacizumab) which inhibit blood vessel growth in tumors, 3) Immunotherapy (e.g., checkpoint inhibitors like pembrolizumab) which enhance the immune system's ability to fight cancer, and 4) Antibody-drug conjugates (e.g., mirvetuximab soravtansine) targeting specific cancer cell markers. These treatments have shown promise in clinical trials and are being integrated into treatment protocols.

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Alkylating agents

HIPEC with Surgery for Ovarian Cancer (OVHIPEC-2 Trial)

Phase 3

Recruiting

Research Sponsored by The Netherlands Cancer Institute

Eligibility Criteria Checklist

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

Must have

Histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer

Be older than 18 years old

Must not have

FIGO stage IV disease

Prior treatment for the current malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after end of treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if combining surgery with heated chemotherapy improves outcomes for patients with stage III ovarian cancer compared to surgery alone. Heated chemotherapy has shown improved disease-free and overall survival in patients with stage III ovarian cancer when combined with surgery to remove as much of the tumor as possible.

Who is the study for?

This trial is for individuals with stage III epithelial ovarian, fallopian tube, or primary peritoneal cancer who are candidates for initial surgery to remove the tumor. They must not have had any other cancers in the past 5 years and should not have received prior treatment for their current cancer.

What is being tested?

The study is testing whether adding hyperthermic intraperitoneal chemotherapy (HIPEC), which involves heating chemotherapy drugs and delivering them directly into the abdominal cavity, improves outcomes when combined with standard surgery compared to surgery alone.

What are the potential side effects?

Possible side effects include those related to cisplatin such as kidney damage, hearing loss, nausea, vomiting, nerve damage leading to numbness or tingling in hands and feet, allergic reactions and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is in stage III and started in the ovary, fallopian tube, or nearby areas.

Exclusion Criteria

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

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My cancer is at the most advanced stage (stage IV).

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I have received treatment for my current cancer.

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It's not possible to remove all of my cancer with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after end of treatment for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

adverse events

cost evaluation

Side effects data

From 2010 Phase 2 trial • 13 Patients • NCT02006667

46%

Platelet count decreased

38%

Nausea

23%

Fatigue

23%

White blood cell decreased

23%

Vomiting

23%

Chills

23%

Dyspnea

15%

Creatinine increased

15%

Urinary tract infection

15%

Anemia

15%

Weight loss

15%

Investigations-other

15%

Back pain

15%

Paresthesia

15%

Epistaxis

Non-cardiac chest pain

Alkaline phosphatase increased

Peripheral sensory neuropathy

Infections and infestations-others

Bone pain

Sinus bradycardia

Eyelid function disorder

General disorders and administration site conditions-other

Diarrhea

Bronchial infection

Nail infection

Fever

Upper respiratory infection

Confusion

Tachyarrhythmia

Gastrointestinal hermorrhage

Ileus

General disorders-other

Catheter related infection

Hematuria

Urinary tract obstruction

Pleural effusion

Vertigo

Endocrine disorders-other

Neutrophil count decreased

Arthralgia

Pain in extremity

Neck pain

Generalized muscle weakness

Neoplasms benign, malignant and unspecified-others

Depression

Alopecia

Nail ridging

Surgical and medical procedures-others

Chill

Gastrointestinal hemorrhage

Arthritis

Pain

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab/Gemcitabine/Cisplatin

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HIPECExperimental Treatment1 Intervention

Primary cytoreductive surgery with HIPEC with cisplatin

Group II: conventional surgeryActive Control1 Intervention

Primary cytoreductive surgery without HIPEC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cisplatin

1997

Completed Phase 3

~3290

0 / 4Eligibility 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

Ovarian cancer treatment typically involves a combination of surgery and chemotherapy. Surgery aims to remove as much of the tumor as possible, which is crucial for reducing the cancer burden. Systemic chemotherapy, often using platinum-based drugs like carboplatin and cisplatin, works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a specialized treatment where heated chemotherapy is directly applied to the abdominal cavity during surgery. The heat enhances the effectiveness of the chemotherapy and helps kill remaining cancer cells that are not visible to the surgeon. This approach is particularly significant for ovarian cancer patients as it targets microscopic residual disease, potentially improving survival rates and reducing recurrence.

Gynecological malignancies.Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study.Is there a role for intraperitoneal chemotherapy in the management of ovarian cancer?