Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

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 IowaIowa City, Iowa  52242
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Southwest Regional Cancer CenterAustin, Texas  78705
Florida Gynecologic OncologyFort Myers, Florida  33901
The West Cancer ClinicMemphis, Tennessee  38120
Jupiter Medical Center-Gynecology Oncology and GynecologyJupiter, Florida  33458
Florida Hospital/Gyn/Onc DepartmentOrlando, Florida  32804
Hematology-Onc. Assoc. of The Quad CitiesBettendorf, Iowa  52722
Franklin Square Hospital Center/MedStar Health-Section of Hematology/OncologyBaltimore, Maryland  21237-3998
Cancer Center at HackensackHackensack, New Jersey  07601
Columbia University College of Physicians and SurgNew York, New York  10032
Hope: A Woman's Cancer CenterAsheville, North Carolina  28816
University of North Carolina/ Division of Gyn OncologyChapel Hill, North Carolina  27599-7570
Carolinas Medical Center/Gyn Oncology DepartmentCharlotte, North Carolina  28232
Duke University/Division of Gynecologic OncologyDurham, North Carolina  27710-0001
Forsyth Regional Cancer CenterWinston-Salem, North Carolina  27103
Gynecologic Oncology and SurgeryOklahoma City, Oklahoma  73112
PA Hematology/Oncology AssociatesPhiladelphia, Pennsylvania  19106
MUSC-Div of Gyn/OncologyCharleston, South Carolina  29425