Clinical trial NCT00814086: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-23
Enrollment: 23
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
timeFrame: Up to 1 year
measure: Adverse events related to the catheter or the surgical placement of the catheter
timeFrame: Up to 1 year
measure: Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Camden
country: United States
facility: Cooper Hospital University Medical Center
state: New Jersey
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Cancer Institute
state: Oklahoma
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Gynecologic Oncology Group
name: Don Dizon
role: PRINCIPAL_INVESTIGATOR
References: