Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003160
First received: November 1, 1999
Last updated: April 19, 2011
Last verified: January 2001
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 100
Study Start Date: September 1997
Detailed Description:

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 survival.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003160

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003160     History of Changes
Other Study ID Numbers: CDR0000065955, THERADEX-B97-3250, BMS-TAX/MEN.03, NCI-V97-1366
Study First Received: November 1, 1999
Last Updated: April 19, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014