Carboplatin Plus Docetaxel and Paclitaxel in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer) - Full Text View

Sponsors and Collaborators:	Gynecologic Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085358

Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug 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 intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage III or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer).

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: carboplatin Drug: docetaxel Drug: paclitaxel	Phase I

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Docetaxel Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Trial Of Intravenous Paclitaxel Intraperitoneal Carboplatin And Intraperitoneal Paclitaxel Or Intravenous Docetaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel In Patients With Previously Untreated Epithelial Ovarian Carcinoma, Fallopian Tube Or Primary Peritoneal Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose (MTD) of intraperitoneal (IP) carboplatin when given in combination with paclitaxel IV followed by IP paclitaxel as assessed by CTC 3.0 toxicity dose delay or reduction at 30 days [ Designated as safety issue: Yes ]
MTD of docetaxel IV, intraperitoneal (IP) carboplatin when given in combination with IP paclitaxel as assessed by CTC 3.0 toxicity dose delay or reduction at 30 days [ Designated as safety issue: Yes ]
Toxicity of the MTD of these regimens as assessed by CTC 3.0 after 6 courses [ Designated as safety issue: Yes ]
Standardize intraperitoneal catheter placement techniques as assessed by complications or port failures after 6 courses [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life as assessed by NTX during each course, every 3 months for 1 year after completion of treatment, and at 1 year after completion of treatment [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2004
Estimated Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose (MTD) of intraperitoneal (IP) carboplatin when given in combination with IV paclitaxel followed by IP paclitaxel in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma.
Determine the MTD of IP carboplatin and IV docetaxel when given in combination with IP paclitaxel in these patients.
Determine the feasibility of treating patients with these regimens.
Determine the dose-limiting toxic effects and complications in patients treated with these regimens.
Evaluate the neurotoxicity of this regimen at each cycle using the FACT/GOG-NTX4 assessment tool to determine dose reduction in these patients.
Evaluate the techniques used for intraperitoneal catheter placement, surgical procedures, and reporting of outcomes in these patients.

OUTLINE: This is a 2-part, multicenter, dose-escalation study of intraperitoneal (IP) carboplatin. Patients in the dose-escalation phase are not eligible to enter the feasibility phase.

Dose-escalation phase: Patients receive IP carboplatin over 15 minutes and paclitaxel IV over 3 hour on day 1 and IP paclitaxel over 15 minutes on day 8.

Cohorts of 3 patients receive escalating dose of IP carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD of IP carboplatin is determined, the study proceeds to the feasibility phase.

Feasibility phase: Patients receive IP carboplatin as in phase I and docetaxel IV over 1 hour on day 1 and IP paclitaxel as in the dose-escalation phase I on day 8.

In both phases, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 3-40 patients will be accrued for this study (3-20 in the dose-escalation phase and 20 in the feasibility phase).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
- Stage III or IV disease
- Optimal (≤ 1 cm residual disease) or suboptimal residual disease
- The following epithelial cell types are allowed:
  - Carcinosarcoma
  - Serous adenocarcinoma
  - Endometrioid adenocarcinoma
  - Mucinous adenocarcinoma
  - Undifferentiated carcinoma
  - Clear cell adenocarcinoma
  - Mixed epithelial carcinoma
  - Transitional cell carcinoma
  - Malignant Brenner's tumor
  - Adenocarcinoma not otherwise specified
Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks
Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met:
- Stage ≤ IB
- Less than 3 mm invasion without vascular or lymphatic invasion
- No poorly differentiated subtypes (e.g., grade 3, clear cell, or papillary serous)
No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
No CNS disease (e.g., seizures not controlled with standard medical therapy) or metastasis

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

GOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
No active bleeding

Hepatic

SGOT ≤ 2.5 times normal*
Alkaline phosphatase ≤ 2.5 times normal*
Bilirubin ≤ 1.5 times normal*
No acute hepatitis NOTE: *≤ 5 times normal if liver metastasis is present

Renal

Creatinine ≤ 1.5 times normal

Cardiovascular

Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided disease has remained stable for the past 6 months
No unstable angina within the past 6 months
No myocardial infarction within the past 6 months

Other

No septicemia or severe infection
No circumstance that would preclude study participation
No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
No other invasive malignancy within the past 5 years except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics

Other

No prior cancer therapy that would contraindicate study treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085358

Locations

United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Recruiting
Orange, California, United States, 92868
Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent 877-UC-STUDY ucstudy@uci.edu
United States, Illinois
University of Chicago Cancer Research Center	Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David G. Mutch, MD 314-362-3181
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees	Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757
United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422
United States, Oklahoma
Cancer Care Associates - Saint Francis Campus	Recruiting
Tulsa, Oklahoma, United States, 74136-1929
Contact: Robert S. Mannel, MD 405-271-8787
Oklahoma University Cancer Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel, MD 405-271-8787
United States, Rhode Island
Women and Infants Hospital of Rhode Island	Recruiting
Providence, Rhode Island, United States, 02905
Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Joan L. Walker, MD	Oklahoma University Cancer Institute
Investigator:	Natalie Gould, MD	Rocky Mountain Cancer Centers - Denver Midtown

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Hsu Y, Sood AK, Sorosky JI. Docetaxel versus paclitaxel for adjuvant treatment of ovarian cancer: case-control analysis of toxicity. Am J Clin Oncol. 2004 Feb;27(1):14-8.

Study ID Numbers:	CDR0000368755, GOG-9916
Study First Received:	June 10, 2004
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00085358
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer
ovarian serous cystadenocarcinoma
ovarian endometrioid adenocarcinoma

ovarian mucinous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma
ovarian mixed epithelial carcinoma
Brenner tumor
ovarian clear cell cystadenocarcinoma
ovarian carcinosarcoma

Study placed in the following topic categories:

Cystadenocarcinoma, Serous
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Carcinoma, Endometrioid
Docetaxel
Genital Diseases, Female
Ovarian carcinosarcoma
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female

Endocrine System Diseases
Carboplatin
Abdominal Neoplasms
Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Digestive System Diseases
Paclitaxel
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Fallopian tube cancer
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinosarcoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009