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Alkylating agents

Chemotherapy +/− Bevacizumab for Ovarian Cancer

Phase 3
Waitlist Available
Led By Robert L Coleman
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
Patients with specific histologic epithelial cell types are eligible
Patients must have had a complete response to front-line platinum-taxane therapy (at least three cycles)
Must not have
Patients receiving concurrent immunotherapy, or radiotherapy
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1. prior to cycle 1 (baseline), 2. prior to cycle 3 (6 weeks post cycle 1), 3. prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying carboplatin, paclitaxel, and gemcitabine hydrochloride given together with or without bevacizumab after surgery to treat patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

Who is the study for?
This trial is for patients with recurrent ovarian, epithelial, primary peritoneal, or fallopian tube cancer who responded well to initial platinum-taxane therapy and had a treatment-free period of at least 6 months. They must have measurable disease and be in good physical condition (GOG performance status of 0-2). Exclusions include those with more than one prior chemo regimen, previous radiotherapy to the abdomen/pelvis, certain other cancers within the last 5 years, severe medical problems unrelated to cancer, significant bleeding risks or CNS disease.
What is being tested?
The study tests if combining chemotherapy drugs carboplatin, paclitaxel and gemcitabine hydrochloride with the immunotherapy drug bevacizumab is more effective post-surgery than chemotherapy alone for treating recurrent ovarian-related cancers. Patients are randomly assigned to receive either just chemo or chemo plus bevacizumab after surgery.
What are the potential side effects?
Possible side effects include fatigue; nausea; hair loss from chemotherapy; high blood pressure; bleeding or blood clots from bevacizumab. There's also a risk of infection due to lowered white blood cell counts and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is of a specific type affecting the lining of organs.
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My cancer responded completely to my initial platinum-taxane therapy.
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My cancer responded completely to initial chemotherapy, with normal exams and CA125 levels.
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I haven't had cancer treatment for 6 months and my cancer hasn't worsened.
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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 agree to let a random selection decide my surgery type.
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My cancer has come back and can be observed.
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My ovarian, peritoneal, or fallopian tube cancer has come back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving immunotherapy or radiotherapy.
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I have not had radiation therapy to my abdomen or pelvis.
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I have not had surgery to remove cancer that came back.
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I have an infection that is not responding to treatment.
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I have not had chemotherapy for any abdominal or pelvic tumor except for ovarian, fallopian tube, or primary peritoneal cancer.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I am not pregnant, nursing, or able to become pregnant without using effective birth control.
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I do not have any conditions that cause serious bleeding.
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I have not had major surgery, dental surgery, or significant injury recently.
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I do not have a history or signs of specific brain or spinal cord diseases.
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I have never had endometrial cancer.
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I do not have any major heart conditions.
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I have had only one chemotherapy regimen for my condition.
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I need IV fluids or nutrition due to partial bowel blockage or a tear.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1. prior to cycle 1 (baseline), 2. prior to cycle 3 (6 weeks post cycle 1), 3. prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1. prior to cycle 1 (baseline), 2. prior to cycle 3 (6 weeks post cycle 1), 3. prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
Secondary study objectives
Patient Reported Physical Function (Chemotherapy Analysis)
Patient Reported Physical Functioning (Surgery Analysis)
Patient Reported Quality of Life (Chemotherapy Analysis)
+4 more

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

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)Experimental Treatment5 Interventions
Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.
Group II: Arm III (gemcitabine hydrochloride, carboplatin)Experimental Treatment4 Interventions
Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.
Group III: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab)Experimental Treatment6 Interventions
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days.
Group IV: Arm I (paclitaxel, docetaxel, carboplatin)Active Control5 Interventions
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
Paclitaxel
2011
Completed Phase 4
~5370
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Carboplatin
2014
Completed Phase 3
~6120
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,920 Previous Clinical Trials
41,015,882 Total Patients Enrolled
NRG OncologyOTHER
238 Previous Clinical Trials
102,043 Total Patients Enrolled
Robert L ColemanPrincipal InvestigatorNRG Oncology

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00565851 — Phase 3
Peritoneal Carcinoma Research Study Groups: Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)
Peritoneal Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00565851 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00565851 — Phase 3
~59 spots leftby Nov 2025
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