Completed

Multicenter, Randomized, Phase II Comparative Study to Compare Efficacy & Safety of Taxotere®/Carboplatin Combination Therapy vs Sequential Therapy w/ Taxotere® Then Carboplatin as Second-line Treatment of Patients w/ Relapsed, Platinum-sensitive Ovarian Cancer

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What is being tested

Docetaxel

+ Carboplatin

Drug
Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorDuke University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

Primary Objective The primary objective of the study is to compare the progression-free survival of two treatment regimens: Taxotere® 30 mg/m2 IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression. (A patient who has completed 6 cycles of treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator's discretion.) Versus Taxotere® 30 mg/m2 IV on Days 1 and 8, repeated every 21 days up to 6 cycles or until disease progression. Followed by carboplatin (AUC 6) IV every 21 days if the patient does not achieve a complete response or has disease progression on Taxotere®. A patient who has achieved a complete response on Taxotere® will be followed until the subsequent recurrence at which time she will then receive single-agent carboplatin. Carboplatin treatment will be discontinued if the patient has completed 6 cycles of treatment and has achieved a complete response or has disease progression. (A patient who has completed 6 cycles of carboplatin treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator's discretion.) Secondary Objectives The secondary objectives of the study are to compare the objective response rates (defined as a complete response plus partial response), duration of tumor response, median survival, QOL and safety in patients treated with the two regimens described above.

Official TitleMulticenter, Randomized, Phase II Comparative Study to Compare Efficacy & Safety of Taxotere®/Carboplatin Combination Therapy vs Sequential Therapy w/ Taxotere® Then Carboplatin as Second-line Treatment of Patients w/ Relapsed, Platinum-sensitive Ovarian Cancer
NCT00090610
Principal SponsorDuke University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

Inclusion Criteria: * Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or tubal carcinoma. * The patient's tumor is platinum-sensitive, which means that the patient had a complete response to front-line treatment with a platinum compound and had a treatment-free interval without clinical evidence of progressive disease for greater than 6 months. * The patient has received one and only one prior chemotherapy regimen for the treatment of this malignancy. Prior treatment with paclitaxel and/or a platinum compound is allowed. Patients who have received consolidation treatment are allowed. Prior treatment with Taxotere® is not allowed. o Consolidation therapy is allowed including a different cytotoxic agent than the agent used in the front-line regimen, intraperitoneal therapy, biologic therapy, and immunotherapy. * Patients may have received one prior regimen with a biologic therapy, either combined with cytotoxic therapy in the front-line setting, or as a single-agent for this recurrence. The biologic therapy must be discontinued at least three weeks prior to registration. * Measurable or evaluable disease either by radiologic imaging, or physical exam, or by measurement of CA125 \< 70 on two occasions at least one week apart. * At least 3 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal. * At least 3 weeks since major surgery, with full recovery. Patients who have undergone a secondary tumor debulking or cytoreductive surgery for this malignancy are excluded. * Eastern Cooperative Oncology Group (ECOG) performance status \< 2. * Age \> 18 years. * Absolute neutrophil count \> 1,500/mm3; platelet count \> 100,000/mm3; Hemoglobin \> 8.0 g/dl * Serum bilirubin Within Normal Limits (WNL); AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility. * If there is childbearing potential, a serum pregnancy test must be negative. * Patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months following the completion of treatment. * Informed consent has been obtained. Exclusion Criteria: * Prior treatment with Taxotere®. * Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the disease. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to enrollment in order for the patient to be eligible to participate in this trial. Continuation of Hormone Replacement therapy is permitted. * Serious concurrent medical or psychiatric illness, including serious active infection. * Peripheral neuropathy \> grade 2. * History of other malignancy within the last 5 years, except for basal cell skin carcinoma. * The patient is pregnant or nursing. * Patients with a history of severe hypersensitivity reaction to cisplatin, carboplatin, mannitol, or drugs formulated with Polysorbate 80. * Secondary debulking for this recurrence.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Docetaxel 30mg/m2 mg IV on Days 1 and 8, in combination with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression

Group II

Experimental
Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression. Once subjects have completed 6 cycles of docetaxel, they receive carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

Florida Gynecologic Oncology

Fort Myers, United StatesOpen Florida Gynecologic Oncology in Google Maps
Suspended

Jupiter Medical Center-Gynecology Oncology and Gynecology

Jupiter, United States
Suspended

Florida Hospital/Gyn/Onc Department

Orlando, United States
Suspended

Hematology-Onc. Assoc. of The Quad Cities

Bettendorf, United States
Completed19 Study Centers