Two Different Schedules of Carboplatin, Paclitaxel, Gemcitabine, and Surgery in Treating Patients With Newly Diagnosed Stage IIIC or Stage IV Primary Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

NCT00838656 | Unknown Phase 2

• 7 other identifiers: CDR0000632859WMS-NEOESCAPE-AK/RH/22498/1ISRCTN24742183EUDRACT-2005-001875-37EU-20904MREC-07/Q2803/73RG_05-003
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, gemcitabine, 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 chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which treatment regimen may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving one of two chemotherapy regimens containing carboplatin, gemcitabine, and paclitaxel works in treating patients undergoing surgery for newly diagnosed primary stage IIIC or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

ovarian carcinosarcoma; stage IIIA ovarian epithelial cancer; stage IIIB ovarian epithelial cancer; stage IIIC ovarian epithelial cancer; stage IV ovarian epithelial cancer; stage IIIA primary peritoneal cavity cancer; stage IIIB primary peritoneal cavity cancer; stage IIIC primary peritoneal cavity cancer; stage IV primary peritoneal cavity cancer; stage IIIA fallopian tube cancer; stage IIIB fallopian tube cancer; stage IIIC fallopian tube cancer; stage IV fallopian tube cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of patients completing 12 courses of chemotherapy

Secondary Outcomes (7)

• Toxicity

• Quality of life as assessed by FACT-G, FACT-0, and FACT-T periodically

• Objective response rate to the neoadjuvant phase of chemotherapy (i.e., first 6 courses) as assessed by CT scan, by laparoscopy, clinically, and by CA-125 level

• Objective response rate following all 12 courses of treatment assessed clinically, by CT scan, and by CA-125 level

• Progression-free survival, particularly at 34 weeks

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive carboplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel

Arm II

EXPERIMENTAL

Patients receive carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo treatment with paclitaxel and may also receive 6 more courses of neoadjuvant chemotherapy. Patients may then undergo surgery. After surgery, patients receive paclitaxel IV over 3 hours and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel

Interventions

carboplatin DRUG

Given IV in one of two schedules

Arm I; Arm II

gemcitabine hydrochloride DRUG

Given IV in one of two schedules

Arm I; Arm II

paclitaxel DRUG

Given IV in one of two schedules

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Clinically, radiologically, and histologically confirmed diagnosis of 1 of the following: * Primary epithelial ovarian cancer * Primary peritoneal carcinoma * Ovarian carcinosarcoma * Fallopian tube carcinoma * Newly diagnosed, stage IIIC/IV disease with or without ascites * None of the following histologies allowed: * Mucinous * Classic clear cell * Micropapillary or microacinar borderline tumors with or without invasive implants * Unsuitable for primary debulking surgery, as defined by the following: * Laparoscopic or other minor surgical-staging procedures * Supplementary clinical and radiological assessments * Presenting with factors affecting suitability for successful complete resection and necessarily prompting laparoscopic assessment, including any of the following: * CT scan or MRI evidence of peritoneal carcinomatosis, extensive mesenteric infiltration, diaphragmatic involvement, extensive retroperitoneal involvement, and cytologically verified malignant pleural effusion and/or ascites * Clinical evidence of ascites with radiological evidence of multisite disease * Clinical evidence of pelvic infiltration and radiological evidence of multisite disease * FIGO stage IV disease, including cervical/supraclavicular lymphadenopathy, intrahepatic parenchymal metastases, or cytologically confirmed malignant pleural effusion * No known brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Life expectancy ≥ 3 months * WBC \> 3.0/mm³ * Platelet count ≥ 100,000/mm³ * ANC ≥ 1,500/mm³ * AST and ALT \< 2.5 times upper limit of normal (ULN) * Alkaline phosphatase \< 2.5 times ULN * Bilirubin \< 1.5 times ULN * Estimated glomerular filtration rate ≥ 30 mL/min * No diabetics, hypertensive smokers, or other patients with pre-existing occult neuropathic deficits * No poorly controlled, potentially serious medical conditions, including any of the following: * Cerebrovascular events within the past 12 months * Severe chronic respiratory conditions requiring prior hospitalization * Active infections * Poorly controlled seizures * Morbid psychiatric conditions likely to render treatment compliance with the protocol difficult * No other malignancy treated with chemotherapy or radiotherapy except nonmelanoma skin cancer or carcinoma in situ of the cervix * Prior malignancies disease-free for \> 5 years not treated with chemotherapy allowed * No other reasons likely to cause inability to comply with treatment schedule and follow-up * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Warwick Medical School: lead

Study Sites (4)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Good Hope Hospital

Birmingham, England, B75 7RR, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Christopher Poole, MD

  University Hospital Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: October 1, 2007
• Primary Completion: June 1, 2009
• Last Updated: September 17, 2013

Record last verified: 2011-06

Locations

GB (4)