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 has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00814086
First received: December 20, 2008
Last updated: August 1, 2013
Last verified: August 2013
  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
Chemotherapeutic Agent Toxicity
Endometrial Cancer
Fallopian Tube Cancer
Gastrointestinal Complications
Neurotoxicity
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: cisplatin
Drug: paclitaxel
Procedure: assessment of therapy complications
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

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 ]

Enrollment: 23
Study Start Date: February 2009
Primary Completion Date: July 2011 (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
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: NCT00814086

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Don S. Dizon, MD Women and Infants Hospital of Rhode Island
Study Chair: Natalie Gould, MD Rocky Mountain Cancer Centers - Denver Midtown
  More Information

Additional Information:
Publications:
Dizon DS, Sill M, Gould NS, et al.: Phase I feasibility study of intraperitoneal cisplatin and intravenous paclitaxel followed by intraperitoneal paclitaxel in untreated ovarian, fallopian tube, and primary peritoneal carcinoma: Gynecologic Oncology Group study 9921. [Abstract] J Clin Oncol 29 (Suppl 15): A-5066, 2011.

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00814086     History of Changes
Other Study ID Numbers: GOG-9921, CDR0000629746, NCI-2009-00624
Study First Received: December 20, 2008
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
neurotoxicity
chemotherapeutic agent toxicity
gastrointestinal complications
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
ovarian serous cystadenocarcinoma
endometrial adenocarcinoma
ovarian mucinous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma
ovarian clear cell cystadenocarcinoma
ovarian mixed epithelial carcinoma
Brenner tumor

Additional relevant MeSH terms:
Endometrial Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neurotoxicity Syndromes
Neoplasms, Glandular and Epithelial
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Neoplasms by Histologic Type
Cisplatin
Paclitaxel
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 11, 2014