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Alkylating agents

Chemotherapy + Bevacizumab for Ovarian & Related Cancers

Phase 3

Waitlist Available

Led By John K Chan

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1

Patients must have a GOG performance status of 0, 1, or 2

Must not have

Patients with clinical symptoms or signs of gastrointestinal obstruction

Patients with metastasis tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patients at high risk of lethal hemorrhage during treatment with bevacizumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two different schedules of paclitaxel given with carboplatin and bevacizumab to treat patients with ovarian, primary peritoneal, or fallopian tube cancer.

Who is the study for?

This trial is for patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Eligible participants must have a certain level of physical fitness (GOG performance status 0-2), adequate organ function, measurable disease, and no prior chemotherapy for abdominal/pelvic tumors. They cannot join if they have certain other health conditions like active bleeding risks or allergies to specific drugs.

What is being tested?

The study tests how well paclitaxel works when given once every three weeks versus weekly in combination with carboplatin and possibly bevacizumab. Bevacizumab is an antibody that blocks blood vessel growth needed by tumors. The effectiveness of these treatments on various types of ovarian-related cancers is being compared.

What are the potential side effects?

Possible side effects include allergic reactions to the drug components, increased risk of bleeding due to bevacizumab's effect on blood vessels, nerve damage (neuropathy), fatigue from chemotherapy agents like paclitaxel and carboplatin, as well as potential liver or kidney function changes.

Eligibility Criteria

Inclusion Criteria

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

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My nerve damage symptoms are mild or not present.

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I can take care of myself but might not be able to do heavy physical work.

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I have ovarian, peritoneal, or fallopian tube cancer at stage II-IV that wasn't fully removed by surgery.

Exclusion Criteria

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

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I am experiencing symptoms of a blockage in my digestive tract.

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My cancer has spread to my liver or lungs near large blood vessels, increasing my risk of serious bleeding with bevacizumab treatment.

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I have ovarian, peritoneal, or fallopian tube cancer treated with surgery only.

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I have a serious heart condition.

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I have previously been treated with drugs targeting blood vessel growth in cancer.

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I have a condition that makes me bleed easily.

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I have moderate to severe issues with blood flow in my limbs.

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I have had chemotherapy for cancer in my abdomen or pelvis before.

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I have or had endometrial cancer along with another primary cancer.

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I have had a stroke in the last six months.

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I have a history or signs of brain or spinal cord disease.

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I have a serious wound, ulcer, or bone fracture that is not healing.

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I have had radiation therapy in my abdomen or pelvis before.

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I have received targeted or hormonal therapy for ovarian, fallopian tube, or peritoneal cancer.

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I have acute hepatitis or an infection needing IV antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-Free Survival

Secondary study objectives

Median Duration of First Quartile Survival

Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

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

Group I: Arm II (neoadjuvant chemotherapy)Experimental Treatment5 Interventions

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.

Group II: Arm I (adjuvant chemotherapy suboptimally debulked)Experimental Treatment5 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Carboplatin

2014