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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

Primary Purpose

Chemotherapeutic Agent Toxicity, Endometrial Adenocarcinoma, Fallopian Tube Carcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Cisplatin
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapeutic Agent Toxicity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center
  • University of Iowa Hospitals and Clinics
  • Cooper Hospital University Medical Center
  • Riverside Methodist Hospital
  • Tulsa Cancer Institute
  • Women and Infants Hospital
  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (paclitaxel, cisplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks

Secondary Outcome Measures

Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Adverse events related to the catheter or the surgical placement of the catheter
Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Full Information

First Posted
December 20, 2008
Last Updated
December 29, 2014
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00814086
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (paclitaxel, cisplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, TAX
Intervention Description
Given IV or intraperitoneally
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Given intraperitoneally
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Time Frame
Up to 1 year
Title
Adverse events related to the catheter or the surgical placement of the catheter
Time Frame
Up to 1 year
Title
Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Dizon
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Tulsa Cancer Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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