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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My nerve damage symptoms are mild or not present.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have ovarian, peritoneal, or fallopian tube cancer at stage II-IV that wasn't fully removed by surgery.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival
Secondary outcome measures
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)
Other outcome measures
Blood Volume Determination
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
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
Carboplatin
2014
Completed Phase 3
~6670
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,461 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
100,160 Total Patients Enrolled
John K ChanPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to Chinese hamster ovary cell products or other genetically engineered antibodies.I am expecting to undergo or have undergone an invasive procedure.I am experiencing symptoms of a blockage in my digestive tract.My cancer has spread to my liver or lungs near large blood vessels, increasing my risk of serious bleeding with bevacizumab treatment.You are not able to have iodinated contrast for a type of CT scan called perfusion CT imaging.Your white blood cell count is at least 1,500 per microliter.Your SGOT level must be less than or equal to 3 times the upper limit of normal.My nerve damage symptoms are mild or not present.I can take care of myself but might not be able to do heavy physical work.I had my diagnostic or staging surgery less than 12 weeks ago.Your blood clotting tests should show normal results.I have ovarian, peritoneal, or fallopian tube cancer treated with surgery only.I have a serious heart condition.I have previously been treated with drugs targeting blood vessel growth in cancer.I have a condition that makes me bleed easily.You are allergic to cremophor or polysorbate 80.I have moderate to severe issues with blood flow in my limbs.I have had chemotherapy for cancer in my abdomen or pelvis before.I have or had endometrial cancer along with another primary cancer.I haven't had any other cancer in the last 5 years that would affect this treatment.I have ovarian, peritoneal, or fallopian tube cancer at stage II-IV that wasn't fully removed by surgery.I have had a stroke in the last six months.I have taken Metformin within 48 hours before my CT scan.I have a history or signs of brain or spinal cord disease.Your alkaline phosphatase levels are not too high.I have had a core tissue biopsy as part of my treatment.Your eligibility for ACRIN 6695 will be determined after the initial perfusion CT scan by the ACR Imaging Core Lab.My cancer is of an epithelial type.Patients must have a measurable disease, meaning there is at least one specific area of the body that can be accurately measured and tracked.All patients in GOG-0262 at sites where ACRIN 6695 is available will be included in the advanced imaging plan.Your platelet count is 100,000 or more per microliter.I have a serious wound, ulcer, or bone fracture that is not healing.Your bilirubin level is less than or equal to 1.5 times the upper limit of normal.Your creatinine levels are not higher than 1.5 times the normal limit at the hospital where you are being treated.I have had radiation therapy in my abdomen or pelvis before.I have received targeted or hormonal therapy for ovarian, fallopian tube, or peritoneal cancer.I may take low-dose hormone therapy for menopause symptoms but not high-dose for appetite loss.I have acute hepatitis or an infection needing IV antibiotics.You have a significant amount of protein in your urine.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (neoadjuvant chemotherapy)
- Group 2: Arm I (adjuvant chemotherapy suboptimally debulked)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary diseases that Paclitaxel has shown to be effective against?
"While malignant neoplasms are the primary condition that can be treated with Paclitaxel, this medication can also be used to ameliorate symptoms for locally advanced nonsquamous non-small cell lung cancer, metastatic colorectal cancer (crc), and as a part of allogeneic stem cell transplantation therapy."
Answered by AI
What other clinical studies have used Paclitaxel?
"As of right now, there are 1522 different ongoing studies that are researching Paclitaxel. Of these trials, 411 are in Phase 3. Moreover, these trials for Paclitaxel are not only based in Shanghai but also in 78234 other locations."
Answered by AI
Has the FDA greenlit Paclitaxel for public consumption?
"Paclitaxel has received a safety score of 3. This is because Phase 3 trials have been conducted, meaning that there is evidence to support both efficacy and safety."
Answered by AI
Could you direct me to how I could sign up for this research project?
"This particular trial, as indicated on clinicaltrials.gov, is not currently seeking patients. The trial was established on September 27th, 2010 but was last updated on September 23rd, 2022. There are 5217 other trials that are open for enrollment."
Answered by AI
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