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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
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00814086
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Cancer-Related Problem/Condition
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: cisplatin
Drug: paclitaxel
Procedure: assessment of therapy complications
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Cisplatin Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day One Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

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

Primary Outcome Measures:
  • The number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks during the first 4 courses of treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Grade of toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Adverse events related to the catheter or the surgical placement of the catheter [ Designated as safety issue: Yes ]
  • Objective tumor response (partial or complete) as assessed by RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy
  • No prior radiotherapy
  • No prior hormonal therapy for the management of epithelial ovarian or primary peritoneal cavity cancer
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814086

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Don S. Dizon, MD Women and Infants Hospital of Rhode Island
Investigator: Natalie Gould, MD Rocky Mountain Cancer Centers - Denver Midtown
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000629746, GOG-9921
Study First Received: December 20, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00814086  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
neurotoxicity
chemotherapeutic agent toxicity
gastrointestinal complications
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer
ovarian serous cystadenocarcinoma
endometrial adenocarcinoma
ovarian mucinous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma
ovarian clear cell cystadenocarcinoma
ovarian mixed epithelial carcinoma
Brenner tumor

Study placed in the following topic categories:
Cystadenocarcinoma, Serous
Tooth Diseases
Neurotoxicity Syndromes
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Dental Caries
Genital Diseases, Female
Endometrial Neoplasms
Cisplatin
Peritoneal Diseases
Uterine Neoplasms
Endometrial cancer
Endocrine Gland Neoplasms
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Neurotoxicity syndromes
Genital Neoplasms, Female
Uterine Diseases
Endocrine System Diseases
Abdominal Neoplasms
Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Digestive System Diseases
Paclitaxel
Gastrointestinal Neoplasms
Endocrinopathy

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Tooth Demineralization
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009