Know Cancer

forgot password

A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer

OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one
hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian
cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the
overall survival in these patients. IV. Assess quality of life in these patients.

OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered
paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks.
Treatment may be delayed for up to 2 weeks and there is no limit to the number of
interruptions a patient may experience. Patients receive paclitaxel weekly until disease
progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and
then every 6 months thereafter during study. Quality of life is assessed every cycle for the
first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for

PROJECTED ACCRUAL: There will be 100 patients accrued into this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is
refractory to an initial chemotherapy regimen that included a platinum agent plus
paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian
tube cancer Initial response to platinum and paclitaxel must have been one of the
following: Progression or stable disease Response that lasted less than 3 months Response
that lasted at least 3 months, but when retreated with both agents (in combination or as
single agents) disease was refractory Measurable or evaluable disease Evaluable disease is
defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from
baseline determination

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal
(ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial
infarction within last 6 months No congestive heart failure No unstable angina No
clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral
neuropathy of any etiology that is greater than grade 1 Other: No active serious infection
or other serious underlying medical condition No prior significant allergic reactions to
drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or
nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No
concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been
administered on a 3 week or greater schedule No other prior chemotherapy besides platinum
and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least
3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3
weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At
least 3 weeks since major surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Maurie Markman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

September 1997

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Brookview Research, Inc. Nashville, Tennessee  37203
Akron General Medical Center Akron, Ohio  44302
Harrington Cancer Center Amarillo, Texas  79106
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Creighton University Cancer Center Omaha, Nebraska  68131-2197
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Good Samaritan Medical Center West Palm Beach, Florida  33401
Jersey Shore Cancer Center Neptune, New Jersey  07753
Hematology Associates, Ltd. Phoenix, Arizona  85013
Oncology Center at Providence Park Mobile, Alabama  36608
Highlands Oncology Group, P.A. Fayetteville, Arkansas  72703
Cancer Center of Santa Barbara Santa Barbara, California  93105
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Women's Health Center at Albany Medical Center Albany, New York  12209
Oncology/Hematology Care, Inc. Cincinnati, Ohio  45219
Women's Cancer Center of Central PA, P.C. Harrisburg, Pennsylvania  17105-8700
Rockwood Clinic P.S. Spokane, Washington  99202