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Alkylating agents

Hyperthermic Intraperitoneal Chemotherapy for Ovarian Cancer

Phase < 1

Recruiting

Led By Floor Backes, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2

Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3/prior to surgery

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia

Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for 3-5 years after study

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing the side effects of hyperthermic intraepithelial chemotherapy with cisplatin before or after surgery in patients with ovarian, fallopian tube, or peritoneal cancer receiving chemotherapy before surgery.

Who is the study for?

This trial is for adults over 18 with stage III or IV ovarian, fallopian tube, or peritoneal cancer who've had some chemo but still need surgery. They should be fit for major surgery and have a good performance status score (0-2). People can't join if they have inflammatory bowel disease, recent other cancers except certain skin cancers and cervical carcinoma in situ, allergies to the drugs used here, or uncontrolled illnesses like heart failure.

What is being tested?

The study tests two approaches: giving heated chemotherapy with cisplatin during surgery versus standard cisplatin before surgery. The goal is to see which method might kill more tumor cells effectively. Participants will also complete quality-of-life questionnaires to assess how these treatments impact their well-being.

What are the potential side effects?

Side effects may include reactions to chemotherapy such as nausea, kidney damage from cisplatin, nerve damage from paclitaxel leading to numbness or tingling in hands and feet, blood count changes increasing infection risk, fatigue and potential complications from major surgery.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of the day.

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My CA-125 levels dropped by at least 50% after 3-4 cycles of chemotherapy before surgery.

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I am considered fit for major surgery according to ASA standards.

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My cancer responded to the initial 3-4 cycles of chemotherapy.

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I have completed 3 cycles of a specific chemotherapy before surgery.

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I am older than 18 years.

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I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

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

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I do not have any uncontrolled illnesses like infections or heart problems.

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I am not eligible if my surgery cannot remove or reduce my cancer significantly.

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I have or had inflammatory bowel disease.

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I am allergic to certain chemotherapy drugs like cisplatin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 3-5 years after study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 3-5 years after study

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 3-5 years after study for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of chemotherapy-related adverse events

Secondary study objectives

Feasibility of chemotherapy immediately perioperatively

Percentage of patients in Arm C with a treatment free interval of < 8 weeks

Quality of life (QOL) assessment EORTC QLQ-C30

+2 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Cerebral infarction

Dyspnoea

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (carboplatin, paclitaxel, CRS, cisplatin)Experimental Treatment6 Interventions

OUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 3 arms. ARM III: Patients receive cisplatin IV the day prior to interval debulking surgery

Group II: Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin)Experimental Treatment7 Interventions

OUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 3 arms. ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval debulking surgery

Group III: Arm I (carboplatin, paclitaxel, CRS)Active Control5 Interventions

OUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 3 arms. ARM I: No chemotherapy immediately before, during or after surgery. Carboplatin/paclitaxel is given 3-4 weeks prior to surgery and again 2-4 weeks after surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

FDA approved

Hyperthermic Intraperitoneal Chemotherapy

2010

Completed Phase 3

~210

Platinum

Not yet FDA approved