Your session is about to expire
← Back to Search
Platinum-based Chemotherapy
Chemotherapy for Ovarian and Related Cancers
Phase 3
Waitlist Available
Led By Matthew A Powell
Research Sponsored by GOG Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
Patients must be chemotherapy naïve as directed against their carcinosarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months.
Awards & highlights
Study Summary
This trial is testing how well two different chemotherapy drugs work compared to each other in treating patients with fallopian tube or peritoneal cavity cancer.
Who is the study for?
This trial is for patients with newly diagnosed, persistent, or recurrent uterine, ovarian, fallopian tube, or peritoneal cavity cancer. They must be in good physical condition (GOG status 0-2), have normal organ function tests, no prior chemotherapy for carcinosarcoma and not currently have infections requiring antibiotics. Women of childbearing age need a negative pregnancy test and must use contraception.Check my eligibility
What is being tested?
The study compares two chemotherapy combinations: paclitaxel with carboplatin versus paclitaxel with ifosfamide to see which is more effective against these cancers. It's a phase III trial where participants are randomly assigned to either treatment group.See study design
What are the potential side effects?
Common side effects may include nausea and vomiting, hair loss, numbness or tingling in hands/feet (neuropathy), low blood cell counts leading to increased infection risk or bleeding problems. Rarely severe allergic reactions can occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have not received chemotherapy for my carcinosarcoma.
Select...
I have a new or returning uterine, ovarian, fallopian tube, or peritoneal cancer.
Select...
I am not currently on antibiotics for an infection.
Select...
My nerve damage does not significantly affect my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Duration of Progression-free Survival
Incidence of Adverse Events as Assessed by CTCAE Version 3.0
Patient Reported Peripheral Neuropathy Symptoms - Baseline
+3 moreSide 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 (paclitaxel, ifosfamide)Experimental Treatment3 Interventions
Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.
Group II: Arm I (paclitaxel, carboplatin)Experimental Treatment3 Interventions
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
GOG FoundationLead Sponsor
41 Previous Clinical Trials
15,504 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,516 Total Patients Enrolled
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,289 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for radiotherapy after or during chemotherapy before my cancer worsens.My cancer can be either seen on scans or not.Your blood platelet count is 100,000 or more per microliter.I haven't had any cancer other than non-melanoma skin cancer in the last 5 years.My cancer diagnosis was confirmed through a biopsy or curettage without staging.I have had radiation therapy as part of my previous cancer treatment.I stopped my hormone therapy for cancer at least a week ago.Your kidney function test shows creatinine levels within a certain range.I can take care of myself but might not be able to do heavy physical work.Your serum albumin level should be 3 grams per deciliter or higher.I have recovered from recent surgery or cancer treatments.Your alkaline phosphatase level is not more than 2.5 times the upper limit of normal.Your SGOT blood test results are not more than 2.5 times the normal level.Your white blood cell count needs to be at least 1,500 per microliter.I have not received chemotherapy for my carcinosarcoma.Your bilirubin levels are within a certain range.You are allergic to medications made from Escherichia (E.) coli bacteria.I do not have a biopsy confirming carcinosarcoma in my uterus, fallopian tube, peritoneum, or ovary.I have a new or returning uterine, ovarian, fallopian tube, or peritoneal cancer.I have had chemotherapy for uterine or ovarian carcinosarcoma.I am not currently on antibiotics for an infection.You are allergic to mesna or similar medicines.I have at least one tumor that can be measured to track my cancer's progress.My nerve damage does not significantly affect my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (paclitaxel, carboplatin)
- Group 2: Arm II (paclitaxel, ifosfamide)
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 other clinical trials has Paclitaxel been used in?
"City of Hope Comprehensive Cancer Center first studied paclitaxel in 1997. As of now, 2635 trials have completed and there are 1979 ongoing studies. A large amount of these active investigations are taking place in Kalamazoo, Michigan."
Answered by AI
Could you inform me how many medical facilities are conducting this experiment?
"There are presently 100 enrolment sites for this study. While some of these are in major cities, others are located in more rural areas. If you want to participate in the trial and live nearby one of the locations, it would be best to select that site so as to avoid travel if possible."
Answered by AI
What does Paclitaxel help to alleviate?
"Paclitaxel can be used to fight non-Hodgkin lymphoma, leukemia, and locally advanced non-small cell lung cancer."
Answered by AI
Has the FDA cleared Paclitaxel for use?
"Paclitaxel has been studied in multiple Phase 3 clinical trials, meaning there is existing data to support both its efficacy and safety."
Answered by AI
Who else is applying?
What site did they apply to?
University of Vermont Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger