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

NCT ID: NCT00331422

Last Updated: 2017-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-03-31

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients Who Received Treatment

All patients receiving treatment with Paclitaxel and Carboplatin followed by surgery to remove cancerous tissue.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Carboplatin dose (milligrams (mg)) - Target Area Under the Curve (AUC) 6 x (Glomerular Filtration Rate+25) - Calvert Formula, given intravenously (IV) for 30 minutes.

paclitaxel

Intervention Type: DRUG

Paclitaxel dose = 175 milligrams per meter squared (mg/m2) over 3 hours.

cytoreductive surgery

Intervention Type: PROCEDURE

Surgery - tumor specimen collected for extreme drug resistant assay (EDR) and A1 assays for analysis

Interventions

carboplatin

Carboplatin dose (milligrams (mg)) - Target Area Under the Curve (AUC) 6 x (Glomerular Filtration Rate+25) - Calvert Formula, given intravenously (IV) for 30 minutes.

Intervention Type: DRUG

paclitaxel

Paclitaxel dose = 175 milligrams per meter squared (mg/m2) over 3 hours.

Intervention Type: DRUG

cytoreductive surgery

Surgery - tumor specimen collected for extreme drug resistant assay (EDR) and A1 assays for analysis

Intervention Type: PROCEDURE

Other Intervention Names

Paraplatin; Taxol; surgery; debulking

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa A. Geller, MD

Role: STUDY_CHAIR

Masonic Cancer Center, University of Minnesota

Locations

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

UMN-0409M64006

Identifier Type: OTHER

Identifier Source: secondary_id

UMN- WCC-40

Identifier Type: OTHER

Identifier Source: secondary_id

2004LS070

Identifier Type: -

Identifier Source: org_study_id