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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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: | 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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2009 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
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 |
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| 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 | |
| Study Chair: | Don S. Dizon, MD | Women and Infants Hospital of Rhode Island |
| Investigator: | Natalie Gould, MD | Rocky Mountain Cancer Centers - Denver Midtown |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00814086 History of Changes |
| Other Study ID Numbers: | CDR0000629746, GOG-9921 |
| Study First Received: | December 20, 2008 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 Adenoma 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 Neoplasms by Histologic Type Nervous System Diseases Poisoning Substance-Related Disorders Cisplatin Paclitaxel |
ClinicalTrials.gov processed this record on May 23, 2013