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
18 Years
N/A
Female
Ovarian Cancer
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival (PFS)
Outcome Description:
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.
Outcome Time Frame:
Every 6 months, to 18 months
Safety Issue:
No
Principal Investigator
Angeles A Secord, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Duke University
Authority:
United States: Food and Drug Administration
Study ID:
Pro00008381 (DUMC03)
NCT ID:
NCT00090610
Start Date:
October 2003
Completion Date:
October 2009
Related Keywords:
- Ovarian Cancer
- Relapsed ovarian cancer
- Ovarian Neoplasms
Name | Location |
|---|---|
| University of Iowa | Iowa City, Iowa 52242 |
| Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
| Southwest Regional Cancer Center | Austin, Texas 78705 |
| Florida Gynecologic Oncology | Fort Myers, Florida 33901 |
| The West Cancer Clinic | Memphis, Tennessee 38120 |
| Jupiter Medical Center-Gynecology Oncology and Gynecology | Jupiter, Florida 33458 |
| Florida Hospital/Gyn/Onc Department | Orlando, Florida 32804 |
| Hematology-Onc. Assoc. of The Quad Cities | Bettendorf, Iowa 52722 |
| Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology | Baltimore, Maryland 21237-3998 |
| Cancer Center at Hackensack | Hackensack, New Jersey 07601 |
| Columbia University College of Physicians and Surg | New York, New York 10032 |
| Hope: A Woman's Cancer Center | Asheville, North Carolina 28816 |
| University of North Carolina/ Division of Gyn Oncology | Chapel Hill, North Carolina 27599-7570 |
| Carolinas Medical Center/Gyn Oncology Department | Charlotte, North Carolina 28232 |
| Duke University/Division of Gynecologic Oncology | Durham, North Carolina 27710-0001 |
| Forsyth Regional Cancer Center | Winston-Salem, North Carolina 27103 |
| Gynecologic Oncology and Surgery | Oklahoma City, Oklahoma 73112 |
| PA Hematology/Oncology Associates | Philadelphia, Pennsylvania 19106 |
| MUSC-Div of Gyn/Oncology | Charleston, South Carolina 29425 |
