COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Cisplatin and Paclitaxel in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00814086
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : December 31, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:
This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Chemotherapeutic Agent Toxicity Endometrial Adenocarcinoma Fallopian Tube Carcinoma Gastrointestinal Complication Malignant Ovarian Mixed Epithelial Tumor Neurotoxicity Syndrome Ovarian Brenner Tumor Ovarian Clear Cell Cystadenocarcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Serous Cystadenocarcinoma Primary Peritoneal Carcinoma Stage II Ovarian Cancer Stage III Ovarian Cancer Stage IV Ovarian Cancer Undifferentiated Ovarian Carcinoma Drug: Paclitaxel Drug: Cisplatin Phase 1

Detailed Description:


I. Determine the feasibility of intraperitoneal (IP) cisplatin and intravenous (IV) paclitaxel followed by IP paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.


I. Assess the toxicity of this regimen in these patients. II. Determine the types of surgical and catheter complications that may occur after surgery or during the course of treatment in these patients.

III. Estimate the response rate in patients with measurable disease treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day 1 Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Study Start Date : February 2009
Actual Primary Completion Date : July 2011

Arm Intervention/treatment
Experimental: Treatment (paclitaxel, cisplatin)
Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Paclitaxel
Given IV or intraperitoneally
Other Names:
  • Anzatax
  • TAX

Drug: Cisplatin
Given intraperitoneally

Primary Outcome Measures :
  1. Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) [ Time Frame: Up to 1 year ]
  2. Adverse events related to the catheter or the surgical placement of the catheter [ Time Frame: Up to 1 year ]
  3. Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer

    • Stage IIB, IIC, III, or IV disease
    • Optimal or suboptimal residual disease after debulking surgery within the past 12 weeks

      • Appropriate tissue for histologic evaluation available
  • The following histologic epithelial cell types are eligible:

    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner tumor
    • Adenocarcinoma not otherwise specified
    • Carcinosarcoma
  • No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
  • No synchronous primary endometrial cancer or a history of primary endometrial cancer unless all of the following conditions are met:

    • Stage ≤ IB disease
    • No more than superficial myometrial invasion, without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • SGOT ≤ 2.5 times ULN
  • Audiograms required after study chemotherapy courses 3 and 6 for patients with hearing loss, or who are experiencing tinnitus during study therapy
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • None of the following:

    • Septicemia
    • Severe infection requiring parenteral antibiotics
    • Malnutrition requiring parenteral hyperalimentation
    • Acute hepatitis
    • Any other major medical conditions expected to interfere with completion of protocol therapy
  • No active bleeding
  • No circumstances that would prohibit completion of study therapy or required follow-up
  • No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
  • No other invasive malignancies, except for nonmelanoma skin cancer or other specific malignancies within the past 5 years, or whose previous cancer treatment contraindicates this protocol therapy
  • No unstable angina or myocardial infarction within the past 6 months

    • Abnormal cardiac conduction (e.g., bundle branch block or heart block) that has been stable for the past 6 months allowed
  • No prior targeted therapy for the management of ovarian epithelial or primary peritoneal cavity cancer including, but not limited to, the following:

    • Vaccines
    • Antibodies
    • Tyrosine kinase inhibitors
  • No prior chemotherapy
  • No prior radiotherapy
  • No prior hormonal therapy for the management of epithelial ovarian or primary peritoneal cavity cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00814086

Layout table for location information
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Oklahoma
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Don Dizon Gynecologic Oncology Group
Layout table for additonal information
Responsible Party: Gynecologic Oncology Group Identifier: NCT00814086    
Other Study ID Numbers: GOG-9921
NCI-2009-00624 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-9921 ( Other Identifier: Gynecologic Oncology Group )
GOG-9921 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cystadenocarcinoma, Serous
Cystadenocarcinoma, Mucinous
Brenner Tumor
Neurotoxicity Syndromes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Nervous System Diseases
Chemically-Induced Disorders
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue