Brief Title
Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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
Brief Summary
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.
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 centimeter 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), tumor protein 53 (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 serum cancer antigen 125 (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 intravenously (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, membrane protein BCL-2,
and multidrug resistant gene 1 (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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy
Secondary Outcome
Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Condition
Fallopian Tube Cancer
Intervention
carboplatin
Study Arms / Comparison Groups
Patients Who Received Treatment
Description: All patients receiving treatment with Paclitaxel and Carboplatin followed by surgery to remove cancerous tissue.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
7
Start Date
October 2005
Completion Date
March 2009
Primary Completion Date
March 2008
Eligibility Criteria
Inclusion Criteria:
- Patients with histological diagnosis of epithelial ovarian, primary peritoneal, or
fallopian tube carcinoma for which no previous treatment has been given.
Patients with the following histological epithelial cell types are eligible:
- Serous adenocarcinoma
- Mucinous adenocarcinoma
- Clear cell adenocarcinoma
- Transitional cell
- Adenocarcinoma not otherwise specified
- Endometrioid adenocarcinoma
- Undifferentiated carcinoma
- Mixed epithelial carcinoma
- Malignant Brenner's tumor
- Measurable or non-measurable disease as defined by Solid Tumor Response Criteria
(RECIST) within 4 weeks of study entry
- High-risk surgical candidate
- Gynecologic Oncology Group (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
- Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times ULN
- Life expectancy ≥ 12 weeks
Exclusion Criteria:
- Pregnant or nursing
- Positive pregnancy test -(Fertile patients must use effective nonhormonal
contraception during and for 3 months after completion of study treatment.)
- History of another neoplasm except for non-metastatic, non-melanoma skin cancers,
carcinoma in situ of the cervix, or cancer cured by surgery > 5 years prior to
registration.
- Septicemia, severe infection, acute hepatitis, or severe gastrointestinal bleeding,
defined as requiring blood transfusion or hospitalization at registration
- Unstable angina will not be eligible. Patients with evidence of abnormal cardiac
conduction (e.g. bundle branch block, heart block) are eligible if their disease has
been stable for the past six months.
- History of severe hypersensitivity or allergic reaction to study drugs, drugs
formulated in Cremophor EL^®, other platinol compounds, or mannitol
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Melissa A. Geller, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00331422
Organization ID
2004LS070
Secondary IDs
UMN-0409M64006
Responsible Party
Sponsor
Study Sponsor
Masonic Cancer Center, University of Minnesota
Study Sponsor
Melissa A. Geller, MD, Study Chair, Masonic Cancer Center, University of Minnesota
Verification Date
December 2017