Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer - Full Text View

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00331422

Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin before surgery works in treating patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy Procedure: antitumor drug screening assay Procedure: conventional surgery Procedure: gene expression profiling Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: laparoscopy Procedure: neoadjuvant therapy	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Carboplatin and Paclitaxel as Neoadjuvant Chemotherapy Followed by Interval Cytoreduction in Women With Advanced Staged Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma for High-Risk Surgical Candidates or Patients Unlikely to be Optimally Surgically Cytoreduced

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

Primary Outcome Measures:

Response in terms of incidence of optimal cytoreduction after neoadjuvant chemotherapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency and severity of toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Change in drug resistance as measured by extreme drug resistance assay after neoadjuvant chemotherapy [ Designated as safety issue: No ]
Change in thrombospondin-1 (TSP-1), p53, and tumor vessel density as measured by immunohistochemistry, angiogenesis assay, and BCL-2 and MDR-1 studies at time of interval debulking after administration of neoadjuvant chemotherapy [ Designated as safety issue: No ]
Quality of life of patients receiving neoadjuvant chemotherapy [ Designated as safety issue: No ]
Tumor response (complete response, partial response, progressive disease, and stable disease) as measured by RECIST after neoadjuvant chemotherapy [ Designated as safety issue: No ]
CA-125 as a measure of optimal cytoreduction [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	October 2005
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine whether at least 50% of patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer are able to achieve optimal cytoreduction (to < 1 cm of remaining disease) after neoadjuvant chemotherapy comprising paclitaxel and carboplatin.

Secondary

Determine the frequency and severity of toxicity associated with this regimen in patients who are high-risk surgical candidates or in patients unlikely to achieve optimal surgical cytoreduction.
Determine if extreme drug resistance assay profiles change after neoadjuvant chemotherapy.
Determine how thrombospondin-1 (TSP-1), p53, and tumor vessel density change after administration of neoadjuvant chemotherapy.
Assess the quality of life of patients receiving neoadjuvant chemotherapy.
Obtain estimates of tumor response after administration of neoadjuvant chemotherapy.
Determine whether CA-125 at the time of cytoreduction is associated with the ability to optimally reduce the patients.

OUTLINE: This is an open-label study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after the fourth course of chemotherapy, patients undergo interval cytoreductive surgery.

Patients who are unable to undergo surgery receive 2 additional courses of chemotherapy and are re-evaluated for surgery after the sixth course of chemotherapy.

Within 4 weeks after surgery, patients receive 2 additional courses of chemotherapy.

Quality of life is assessed periodically.

Tumor samples are obtained via laparoscopic or percutaneous biopsy prior to beginning chemotherapy and during interval cytoreduction. Tissue is examined by immunohistochemistry staining for p53, TSP-1, microvessel density (CD31), angiogenesis, BCL-2, and MDR-1. Gene array analysis and extreme drug resistant assays are also performed.

After completion of study treatment, patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically diagnosed* with 1 of the following:
- Ovarian epithelial cancer
  - No low malignant potential (borderline tumor)
- Primary peritoneal cavity cancer
- Fallopian tube cancer NOTE: * Histologic diagnosis may be confirmed by laparoscopic or radioguided biopsy or by collection of abdominal ascites or pleural fluid
Previously untreated disease
Any of the following histological subtypes are allowed:
- Serous adenocarcinoma
- Mucinous adenocarcinoma
- Clear cell adenocarcinoma
- Transitional cell
- Adenocarcinoma not otherwise specified
- Endometrioid adenocarcinoma
- Undifferentiated carcinoma
- Mixed epithelial carcinoma
- Malignant Brenner's tumor
Extensive tumor burden, defined as ≥ 1 of the following by CT scan:
- Diffuse peritoneal thickening, defined as ≥ 4 mm, involving ≥ 2 of the following areas:
  - Lateral colic gutters
  - Lateral conal fascia
  - Anterior abdominal wall
  - Diaphragm
  - Pelvic peritoneal reflections
- Large-volume ascites, defined as presence of ascites on ≥ 2/3 of CT scan
- Attachment of the omentum to the spleen or disease ≥ 2 cm on any of the following by CT scan:
  - Diaphragm
  - Liver surface or parenchyma
  - Pleura
  - Mesentery
  - Gallbladder fossa
  - Suprarenal paraaortic nodes
- Medical comorbidities such that patient is not considered a candidate for optimal cytoreductive surgery as determined by treating physician
Measurable or evaluable disease
High-risk surgical candidate

PATIENT CHARACTERISTICS:

GOG performance status 0-3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine ≤ 1.5 mg/dL
Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
SGOT ≤ 3 times ULN
Life expectancy ≥ 12 weeks
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment
No history of any other neoplasm, excluding nonmetastatic, nonmelanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery > 5 years prior to study entry
No septicemia, severe infection, acute hepatitis, or severe gastrointestinal bleeding, defined as requiring blood transfusion or hospitalization at registration
No unstable angina
Evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided disease stable for the past 6 months
No history of severe hypersensitivity or allergic reaction to study drugs, drugs formulated in Cremophor EL^®, other platinol compounds, or mannitol

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331422

Locations

United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Study Chair:

Melissa A. Geller, MD

Masonic Cancer Center, University of Minnesota

More Information

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

Responsible Party:	Masonic Cancer Center at University of Minnesota ( Melissa A. Geller )
Study ID Numbers:	CDR0000468850, UMN-2004LS070, UMN-0409M64006, UMN- WCC-40
Study First Received:	May 30, 2006
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00331422
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian mucinous cystadenocarcinoma
ovarian serous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma

stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer
Brenner tumor

Study placed in the following topic categories:

Cystadenocarcinoma, Serous
Tooth Diseases
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Carcinoma, Endometrioid
Dental Caries
Genital Diseases, Female
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
Stomatognathic Diseases
Peritoneal Neoplasms
Fallopian tube cancer
Adenocarcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Tooth Demineralization
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009