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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00814086

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

3.3

Patients Per Site

Study Details

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.

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

PRIMARY OBJECTIVES:

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:

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.
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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment (paclitaxel, cisplatin)

Drug: Paclitaxel

Given IV or intraperitoneally

Other Names:

Anzatax

TAX

Drug: Cisplatin

Given intraperitoneally

Outcome Measures

Primary Outcome Measures

Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks [12 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
2	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
3	Cooper Hospital University Medical Center	Camden	New Jersey	United States	08103
4	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
5	Tulsa Cancer Institute	Tulsa	Oklahoma	United States	74146
6	Women and Infants Hospital	Providence	Rhode Island	United States	02905
7	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792