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Anti-tumor antibody

Carboplatin + Paclitaxel + Bevacizumab for Ovarian Cancer

Phase 1
Waitlist Available
Led By David O'Malley, MD
Research Sponsored by David O'Malley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have adequate bone marrow function, renal function, hepatic function, neurologic function, blood coagulation parameters within normal limits.
Histology diagnoses epithelial ovarian, primary peritoneal, or fallopian tube (Stage II, III or IV) either optimal or suboptimal after initial surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 monthes for 2 years, every 6 months for 3 years.
Awards & highlights

Study Summary

This trial is to see if a new cancer treatment is safe and has fewer side effects than current treatments.

Who is the study for?
This trial is for adults with advanced ovarian, peritoneal, or fallopian tube cancer who haven't had chemotherapy. They must have had surgery within the last 12 weeks and be in good physical condition with proper organ function. Excluded are those under 18, with prior treatments other than surgery, active infections or bleeding, unstable heart conditions, certain past cancers except localized breast cancer and nonmelanoma skin cancer.Check my eligibility
What is being tested?
The study tests intraperitoneal carboplatin combined with IV paclitaxel and bevacizumab in patients who haven't been treated for their ovarian carcinoma before. The goal is to find a safe dosage level and understand the toxicity of this combination therapy during its first phase.See study design
What are the potential side effects?
Possible side effects include allergic reactions (especially if sensitive to polysorbate 80), issues from drug infusion like soreness or infection at injection site, bleeding risks due to blood coagulation changes, liver/kidney/bone marrow/neurologic function impairment due to organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood, kidney, liver, brain functions, and blood clotting are all normal.
Select...
My diagnosis is advanced ovarian, peritoneal, or fallopian tube cancer.
Select...
I had surgery for ovarian, peritoneal, or fallopian tube cancer with tissue samples taken.
Select...
My cancer is one of the specified types of epithelial cell cancer.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I had surgery for diagnosis within the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 monthes for 2 years, every 6 months for 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 monthes for 2 years, every 6 months for 3 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
Response Rate, Progression Free Survival and Overall Survival

Side effects data

From 2022 Phase 3 trial • 1301 Patients • NCT03038100
60%
ALOPECIA
51%
NAUSEA
45%
ARTHRALGIA
44%
ANAEMIA
38%
FATIGUE
35%
DIARRHOEA
35%
CONSTIPATION
35%
HYPERTENSION
30%
NEUTROPENIA
28%
PERIPHERAL SENSORY NEUROPATHY
28%
ABDOMINAL PAIN
28%
NEUTROPHIL COUNT DECREASED
24%
NEUROPATHY PERIPHERAL
24%
RASH
23%
HEADACHE
23%
VOMITING
22%
WHITE BLOOD CELL COUNT DECREASED
22%
MYALGIA
21%
PROTEINURIA
21%
PLATELET COUNT DECREASED
21%
THROMBOCYTOPENIA
21%
EPISTAXIS
19%
DECREASED APPETITE
18%
HYPOTHYROIDISM
17%
URINARY TRACT INFECTION
16%
PYREXIA
16%
COUGH
15%
STOMATITIS
14%
BACK PAIN
14%
INSOMNIA
14%
HYPOMAGNESAEMIA
14%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
DYSPNOEA
14%
PRURITUS
13%
WEIGHT DECREASED
13%
PAIN IN EXTREMITY
12%
DIZZINESS
12%
ASTHENIA
12%
INFUSION RELATED REACTION
11%
LEUKOPENIA
11%
HYPOKALAEMIA
10%
UPPER RESPIRATORY TRACT INFECTION
9%
DYSGEUSIA
8%
ABDOMINAL PAIN UPPER
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
FEBRILE NEUTROPENIA
8%
HYPERTHYROIDISM
7%
DYSPHONIA
7%
MUCOSAL INFLAMMATION
7%
PARAESTHESIA
7%
BONE PAIN
7%
MUSCULAR WEAKNESS
7%
HYPONATRAEMIA
7%
LYMPHOCYTE COUNT DECREASED
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
OEDEMA PERIPHERAL
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
MALAISE
5%
DEPRESSION
5%
DRY MOUTH
5%
VISION BLURRED
5%
DRY SKIN
5%
URTICARIA
5%
HOT FLUSH
5%
PAIN
5%
NECK PAIN
5%
NASAL CONGESTION
4%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
PNEUMONIA
2%
ILEUS
2%
PULMONARY EMBOLISM
2%
COLITIS
2%
SMALL INTESTINAL OBSTRUCTION
1%
PERITONITIS
1%
INTESTINAL OBSTRUCTION
1%
DEHYDRATION
1%
LIVER INJURY
1%
TRANSIENT ISCHAEMIC ATTACK
1%
PNEUMONITIS
1%
ABDOMINAL ABSCESS
1%
INFECTED LYMPHOCELE
1%
PYELONEPHRITIS
1%
UROSEPSIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Placebo With Paclitaxel, Carboplatin and Bevacizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Carboplatin Paclitaxel & BevacizumabExperimental Treatment3 Interventions
Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Carboplatin
FDA approved
Bevacizumab
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

David O'MalleyLead Sponsor
1 Previous Clinical Trials
38 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,671 Total Patients Enrolled
32 Trials studying Ovarian Cancer
1,939 Patients Enrolled for Ovarian Cancer
David O'Malley, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
191 Total Patients Enrolled
1 Trials studying Ovarian Cancer
153 Patients Enrolled for Ovarian Cancer

Media Library

Bevacizumab (Anti-tumor antibody) Clinical Trial Eligibility Overview. Trial Name: NCT01220154 — Phase 1
Ovarian Cancer Research Study Groups: Carboplatin Paclitaxel & Bevacizumab
Ovarian Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01220154 — Phase 1
Bevacizumab (Anti-tumor antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01220154 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project accommodating participants who are over 50?

"This medical trial has a set of eligibility requirements, with the lower limit being 18 years old and the upper age capped at 90."

Answered by AI

Who meets the criteria to participate in this research?

"This trial requires 9 volunteers aged 18-90 with a history of pharmacotherapy. Additionally, applicants must have healthy bone marrow and renal function, normal neurological results; their blood clotting ability needs to be regular, GOG performance status 0-2, and the study entry date cannot exceed 12 weeks since their diagnosis surgery."

Answered by AI

Can you elaborate on other investigations made regarding Carboplatin?

"Presently, there are 1,450 studies underway analyzing the efficacy of Carboplatin. Of these trials, 393 are in their third phase and 76483 treatment centres across the globe are participating. The most prolific area for research is Shanghai; however a multitude of other cities also have operations running."

Answered by AI

In what contexts is Carboplatin typically employed?

"Carboplatin is a common choice when treating malignant neoplasms, and it has been used to treat locally advanced nonsquamous non-small cell lung cancer, metastatic colorectal cancer (crc), as well as providing conditioning regimens for allogeneic stem cell transplantation therapy."

Answered by AI

What safety measures are taken when administering Carboplatin to patients?

"Relative to other medications, the safety of Carboplatin is rated as a 1 due to its current Phase 1 status. That being said, there are some preliminary data that suggests efficacy and minimal risk associated with this drug."

Answered by AI

How many participants are currently involved in this trial?

"At this juncture, this trial is not recruiting. Initially posted on October 1st 2010 and last modified in 2016, the study remains inactive. If you are still seeking out studies to join, 694 pharmacological trials currently require participants and 1450 Carboplatin-based research projects accept patients as well."

Answered by AI

Are researchers actively searching for participants in this experiment?

"Unfortunately, this clinical trial is not actively enrolling patients at the moment. It was initially posted on October 1st 2010 and its information was last updated on October 12th 2016. Should you be interested in other studies that are currently recruiting participants, 694 trials related to pharmacotherapy and 1450 with Carboplatin have available spots."

Answered by AI
~1 spots leftby Mar 2025