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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
Must not have
Patients who are not biopsy proven to have carcinosarcoma of the uterus, fallopian tube, peritoneum or ovary
Patients who have received prior cytotoxic chemotherapy for management of uterine or ovarian 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
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 20 Other Conditions

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.
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.
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a biopsy confirming carcinosarcoma in my uterus, fallopian tube, peritoneum, or ovary.
Select...
I have had chemotherapy for uterine or ovarian 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Duration of Progression-free Survival
Incidence of Adverse Events as Assessed by CTCAE Version 3.0
Patient Reported Peripheral Neuropathy Symptoms - Baseline
+3 more

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
9%
Musculoskeletal pain
9%
Headache
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

Awards & Highlights

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

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
46 Previous Clinical Trials
17,013 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,533 Total Patients Enrolled
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
64,544 Total Patients Enrolled
Matthew A PowellPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
325 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00954174 — Phase 3
Mixed Mullerian Tumor Research Study Groups: Arm I (paclitaxel, carboplatin), Arm II (paclitaxel, ifosfamide)
Mixed Mullerian Tumor Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00954174 — Phase 3
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00954174 — Phase 3
~39 spots leftby Dec 2025
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