Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer
- Registration Number
- NCT00090610
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
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Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or tubal carcinoma.
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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.
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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.
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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.
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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.
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At least 3 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal.
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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.
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Eastern Cooperative Oncology Group (ECOG) performance status < 2.
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Age > 18 years.
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Absolute neutrophil count > 1,500/mm3; platelet count > 100,000/mm3; Hemoglobin > 8.0 g/dl
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Serum bilirubin Within Normal Limits (WNL); AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
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If there is childbearing potential, a serum pregnancy test must be negative.
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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.
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Informed consent has been obtained.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 - Combination Therapy Docetaxel 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 Arm 1 - Combination Therapy Carboplatin 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 Arm 2 - Sequential Therapy Docetaxel 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. Arm 2 - Sequential Therapy Carboplatin 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.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Every 6 months, to 18 months Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression
Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease.
- Secondary Outcome Measures
Name Time Method Quality of Life Baseline performed 14 days before first dose, then every other cycle and at study termination Quality of Life was measured using the Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, version 4. The TOI portion of the FACT-O included questions related to Physical well-being (PWB), Social/Family well-being (FWB), and an ovarian cancer specific module (OCS). The PWB score range is from 0-28; the FWB score range is from 0-28; the OCS score range is from 0-44; this gives the TOI a score range from 0-100. (TOI = PWB + FWB + OCS)
With these instruments, a higher score indicates better health-related quality of life.Objective Response Rate Every 6 months, starting at 12 months to 24 months Complete response rate plus partial response rate, where: Complete response (CR) is defined as disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart and normalization of elevated CA125 in cases of ovarian cancer; Partial response (PR) for measurable disease is defined \>= 30% decrease in the sum of the longest dimensions of all target measurable lesions with no unequivocal progression of non-target lesions as well as no new lesions, with documentation by two disease assessments at least four weeks apart. PR according to CA125 levels is defined as a 50% decrease in CA125 levels where two initial samples were elevated and the sample that shows the 50% is confirmed by a fourth sample 28 days after the prior sample.
OR = CR + PRRecurrence-Free Survival Every 6 months starting at 12 months, to 24 months Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.
Median Overall Survival Every 6 months starting at 12 months, to 24 months
Trial Locations
- Locations (19)
Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology
🇺🇸Baltimore, Maryland, United States
Hope: A Woman's Cancer Center
🇺🇸Asheville, North Carolina, United States
Columbia University College of Physicians and Surg
🇺🇸New York, New York, United States
Hematology-Onc. Assoc. of The Quad Cities
🇺🇸Bettendorf, Iowa, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Carolinas Medical Center/Gyn Oncology Department
🇺🇸Charlotte, North Carolina, United States
PA Hematology/Oncology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Florida Hospital/Gyn/Onc Department
🇺🇸Orlando, Florida, United States
Duke University/Division of Gynecologic Oncology
🇺🇸Durham, North Carolina, United States
University of North Carolina/ Division of Gyn Oncology
🇺🇸Chapel Hill, North Carolina, United States
Forsyth Regional Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Gynecologic Oncology and Surgery
🇺🇸Oklahoma City, Oklahoma, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
MUSC-Div of Gyn/Oncology
🇺🇸Charleston, South Carolina, United States
The West Cancer Clinic
🇺🇸Memphis, Tennessee, United States
Florida Gynecologic Oncology
🇺🇸Fort Myers, Florida, United States
Jupiter Medical Center-Gynecology Oncology and Gynecology
🇺🇸Jupiter, Florida, United States
Cancer Center at Hackensack
🇺🇸Hackensack, New Jersey, United States