Study Published in 'Journal of Clinical Oncology' Shows Carboplatin/Docetaxel Combination is Promising First-Line Therapy for Gynecologic Cancers

Findings Suggest Role for Docetaxel in Treatment of Advanced Ovarian Cancer



Apr 02, 2001, 01:00 ET from Cleveland Clinic

    CLEVELAND, April 2 /PRNewswire/ -- Combination chemotherapy with
 carboplatin and docetaxel (Taxotere(R)) is a highly active and generally
 well-tolerated regimen when used as initial therapy in women with gynecologic
 cancers, including cancers of the ovary, fallopian tubes and the peritoneum,
 investigators from the Cleveland Clinic Foundation report in a study published
 in the April 1st issue of Journal of Clinical Oncology.
     Results from this phase II clinical trial showed an objective response
 rate of 81 percent in evaluable patients who received first-line chemotherapy
 with the platinum agent, carboplatin, in combination with the taxane,
 docetaxel.  Standard GOG (Gynecologic Oncology Group) response criteria for
 measurable disease were employed in this trial.  In addition, decreases in the
 level of Ca-125 antigen were considered evidence of response in the absence of
 other measurable or evaluable disease.  Ca-125 is a protein found in the blood
 that tends to be increased in women with ovarian cancer.
     "While there have been improvements over the past 20 years in the
 prognosis of patients with gynecologic cancers, treatment remains less than
 completely satisfactory," said Maurie Markman, MD, chairman of the department
 of hematology/oncology, director of the Cleveland Clinic Taussig Cancer Center
 in Cleveland, Ohio, and lead investigator of the study.  "Our finding that the
 carboplatin/docetaxel combination is safe and effective as first-line therapy
 merits further exploration of the role of docetaxel in the management of
 advanced ovarian cancer."
     The study included 50 women with a histologically confirmed diagnosis of
 ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who had
 not previously received chemotherapy for their malignancy.  Patients with a
 prior history of another malignancy such as skin or breast cancer were
 eligible for the trial, provided they were disease-free for at least two
 years.  All study participants had measurable or evaluable disease, were
 18 years of age or older, and had an ECOG performance status of 0 to 2.
     The study included 36 patients with a histologically confirmed diagnosis
 of ovarian cancer, one with fallopian tube cancer, and 13 with primary
 peritoneal cancer.  Because fallopian tube cancer and primary peritoneal
 cancer are generally considered to be identical to ovarian cancer with
 respect to the cell of origin, prognosis, and response to chemotherapy,
 patients with these two malignancies were considered suitable for enrollment
 in the trial.
     All patients were treated with carboplatin AUC 6 administered
 intravenously over 30 minutes and docetaxel, 60 mg/m2, administered
 intravenously over one hour.  The term AUC refers to a dosing calculation
 based on kidney function.  The treatment was repeated six times, with three
 weeks in between treatment.
     Objective responses were observed in 34 of 42 evaluable patients, or
 81 percent.  "These responses were associated with improvement of symptoms of
 the cancer," Dr. Markman said.
     All patients were evaluable for toxicity.  Thirty-two patients
 (64 percent) experienced severe neutropenia (a low white blood cell count),
 and 17 (34 percent) had hypersensitivity reactions that were not severe enough
 to require that the treatment be discontinued.  Three patients (six percent)
 developed a peripheral neuropathy (injury to the nerves that supply sensation
 to the arms and legs).  The treatment dose had to be reduced in 33 patients
 (66 percent), usually because of severe neutropenia.
     "The safety data show that neurotoxicity was not a significant problem
 with treatment, and the low incidence of neuropathy is particularly
 noteworthy," Dr. Markman said.  "The data suggest that a patient at high risk
 for developing peripheral neuropathy might fare better on a
 docetaxel-containing chemotherapy combination."
     Ovarian cancer is a malignant tumor of the ovary and one of the most
 common gynecologic malignancies.  It accounts for four percent of all cancers
 among women and ranks second among gynecologic cancers.  The disease is often
 curable when detected early, but because it does not produce any symptoms in
 its earliest stages, most women have widespread disease at the time of
 diagnosis.  Approximately 75 percent of ovarian cancer patients survive one
 year after diagnosis.  The five-year relative survival rate for all stages is
 50 percent.
     The Cleveland Clinic Foundation, founded in 1921, integrates clinical and
 hospital care with research and education in a private, non-profit group
 practice.  Approximately 1,100 full-time salaried physicians at the Cleveland
 Clinic and Cleveland Clinic Florida, representing more than 100 medical
 specialties and subspecialties, provided care through more than 1.7 million
 outpatient visits and 50,000 hospital admissions in 1999 for patients from
 throughout the United States and more than 80 countries.
     With more than 3,000 available beds, the Cleveland Clinic Health System,
 formed in 1996, offers broad geographic coverage and a full continuum of high
 quality care.  It includes The Cleveland Clinic Foundation, Cleveland Clinic
 Florida, a multi-specialty group practice and hospital, and the Cleveland
 Clinic Children's Hospital for Rehabilitation.  The Cleveland Clinic Health
 System also includes ten respected community-based providers: Ashtabula County
 Medical Center and Euclid, Fairview, Grace, Hillcrest, Huron, Lakewood,
 Lutheran, Marymount and South Pointe hospitals.
     The institution's Taussig Cancer Center offers a comprehensive range of
 services, including advanced treatment modalities, research studies, and
 technological resources.  Because the facility is a research and teaching
 center, its physicians, scientists, and technicians have extensive experience
 dealing with rare and difficult cancers.
 
 

SOURCE Cleveland Clinic
    CLEVELAND, April 2 /PRNewswire/ -- Combination chemotherapy with
 carboplatin and docetaxel (Taxotere(R)) is a highly active and generally
 well-tolerated regimen when used as initial therapy in women with gynecologic
 cancers, including cancers of the ovary, fallopian tubes and the peritoneum,
 investigators from the Cleveland Clinic Foundation report in a study published
 in the April 1st issue of Journal of Clinical Oncology.
     Results from this phase II clinical trial showed an objective response
 rate of 81 percent in evaluable patients who received first-line chemotherapy
 with the platinum agent, carboplatin, in combination with the taxane,
 docetaxel.  Standard GOG (Gynecologic Oncology Group) response criteria for
 measurable disease were employed in this trial.  In addition, decreases in the
 level of Ca-125 antigen were considered evidence of response in the absence of
 other measurable or evaluable disease.  Ca-125 is a protein found in the blood
 that tends to be increased in women with ovarian cancer.
     "While there have been improvements over the past 20 years in the
 prognosis of patients with gynecologic cancers, treatment remains less than
 completely satisfactory," said Maurie Markman, MD, chairman of the department
 of hematology/oncology, director of the Cleveland Clinic Taussig Cancer Center
 in Cleveland, Ohio, and lead investigator of the study.  "Our finding that the
 carboplatin/docetaxel combination is safe and effective as first-line therapy
 merits further exploration of the role of docetaxel in the management of
 advanced ovarian cancer."
     The study included 50 women with a histologically confirmed diagnosis of
 ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who had
 not previously received chemotherapy for their malignancy.  Patients with a
 prior history of another malignancy such as skin or breast cancer were
 eligible for the trial, provided they were disease-free for at least two
 years.  All study participants had measurable or evaluable disease, were
 18 years of age or older, and had an ECOG performance status of 0 to 2.
     The study included 36 patients with a histologically confirmed diagnosis
 of ovarian cancer, one with fallopian tube cancer, and 13 with primary
 peritoneal cancer.  Because fallopian tube cancer and primary peritoneal
 cancer are generally considered to be identical to ovarian cancer with
 respect to the cell of origin, prognosis, and response to chemotherapy,
 patients with these two malignancies were considered suitable for enrollment
 in the trial.
     All patients were treated with carboplatin AUC 6 administered
 intravenously over 30 minutes and docetaxel, 60 mg/m2, administered
 intravenously over one hour.  The term AUC refers to a dosing calculation
 based on kidney function.  The treatment was repeated six times, with three
 weeks in between treatment.
     Objective responses were observed in 34 of 42 evaluable patients, or
 81 percent.  "These responses were associated with improvement of symptoms of
 the cancer," Dr. Markman said.
     All patients were evaluable for toxicity.  Thirty-two patients
 (64 percent) experienced severe neutropenia (a low white blood cell count),
 and 17 (34 percent) had hypersensitivity reactions that were not severe enough
 to require that the treatment be discontinued.  Three patients (six percent)
 developed a peripheral neuropathy (injury to the nerves that supply sensation
 to the arms and legs).  The treatment dose had to be reduced in 33 patients
 (66 percent), usually because of severe neutropenia.
     "The safety data show that neurotoxicity was not a significant problem
 with treatment, and the low incidence of neuropathy is particularly
 noteworthy," Dr. Markman said.  "The data suggest that a patient at high risk
 for developing peripheral neuropathy might fare better on a
 docetaxel-containing chemotherapy combination."
     Ovarian cancer is a malignant tumor of the ovary and one of the most
 common gynecologic malignancies.  It accounts for four percent of all cancers
 among women and ranks second among gynecologic cancers.  The disease is often
 curable when detected early, but because it does not produce any symptoms in
 its earliest stages, most women have widespread disease at the time of
 diagnosis.  Approximately 75 percent of ovarian cancer patients survive one
 year after diagnosis.  The five-year relative survival rate for all stages is
 50 percent.
     The Cleveland Clinic Foundation, founded in 1921, integrates clinical and
 hospital care with research and education in a private, non-profit group
 practice.  Approximately 1,100 full-time salaried physicians at the Cleveland
 Clinic and Cleveland Clinic Florida, representing more than 100 medical
 specialties and subspecialties, provided care through more than 1.7 million
 outpatient visits and 50,000 hospital admissions in 1999 for patients from
 throughout the United States and more than 80 countries.
     With more than 3,000 available beds, the Cleveland Clinic Health System,
 formed in 1996, offers broad geographic coverage and a full continuum of high
 quality care.  It includes The Cleveland Clinic Foundation, Cleveland Clinic
 Florida, a multi-specialty group practice and hospital, and the Cleveland
 Clinic Children's Hospital for Rehabilitation.  The Cleveland Clinic Health
 System also includes ten respected community-based providers: Ashtabula County
 Medical Center and Euclid, Fairview, Grace, Hillcrest, Huron, Lakewood,
 Lutheran, Marymount and South Pointe hospitals.
     The institution's Taussig Cancer Center offers a comprehensive range of
 services, including advanced treatment modalities, research studies, and
 technological resources.  Because the facility is a research and teaching
 center, its physicians, scientists, and technicians have extensive experience
 dealing with rare and difficult cancers.
 
 SOURCE  Cleveland Clinic