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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00624 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| GOG-9921 | |||
| CDR0000629746 | |||
| GOG-9921 | Other Identifier | Gynecologic Oncology Group | |
| GOG-9921 | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (paclitaxel, cisplatin) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Given IV or intraperitoneally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
The following histologic epithelial cell types are eligible:
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:
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:
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
No prior targeted therapy for the management of ovarian epithelial or primary peritoneal cavity cancer including, but not limited to, the following:
No prior chemotherapy
No prior radiotherapy
No prior hormonal therapy for the management of epithelial ovarian or primary peritoneal cavity cancer
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| Name | Affiliation | Role |
|---|---|---|
| Don Dizon | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States | ||
| University of Iowa Hospitals and Clinics |
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| Cisplatin | Drug | Given intraperitoneally |
|
| Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) | Up to 1 year |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Tulsa Cancer Institute | Tulsa | Oklahoma | 74146 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| D001948 | Brenner Tumor |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010049 | Ovarian Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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