Carboplatin Plus Paclitaxel or Docetaxel in Treating Patients With Ovarian Epithelial Cancer

NCT00003998 | Completed Phase 3

• 3 other identifiers: CDR0000067208CRC-BOC-SCOTROCEU-99010
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for treating ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with that of carboplatin plus docetaxel in treating patients who have ovarian epithelial cancer.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; primary peritoneal cavity cancer

Interventions

carboplatin DRUG

docetaxel DRUG

paclitaxel DRUG

surgical procedure PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed stage IC-IV ovarian epithelial cancer IC must have malignant cells in ascitic fluid or peritoneal washing, have tumor on surface of the ovary, or have preoperative capsule rupture OR Peritoneal carcinomatosis (ovarian-type) No evidence of primary fallopian tube carcinoma No mixed mesodermal tumors No borderline ovarian tumors or tumors termed possibly malignant PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) OR ALT or AST no greater than 1.5 times ULN OR Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No hypertension No ischemic heart disease No myocardial infarction within the past 6 months No congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled infection No other concurrent severe and/or uncontrolled comorbid medical condition No prior malignancy within the past 5 years, except: Curatively treated carcinoma in situ of the cervix Basal cell skin cancer No other concurrent malignancy (e.g., endometrial cancer) No prior serious allergic reaction (e.g., anaphylactic shock) No symptomatic grade 2 or greater peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Prior surgery allowed

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

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

C.R.C. Beatson Laboratories

Glasgow, Scotland, G61 1BD, United Kingdom

Location

Related Publications (3)

• Marsh S, Paul J, King CR, Gifford G, McLeod HL, Brown R. Pharmacogenetic assessment of toxicity and outcome after platinum plus taxane chemotherapy in ovarian cancer: the Scottish Randomised Trial in Ovarian Cancer. J Clin Oncol. 2007 Oct 10;25(29):4528-35. doi: 10.1200/JCO.2006.10.4752.

  PMID: 17925548 RESULT

• Crawford SC, Vasey PA, Paul J, Hay A, Davis JA, Kaye SB. Does aggressive surgery only benefit patients with less advanced ovarian cancer? Results from an international comparison within the SCOTROC-1 Trial. J Clin Oncol. 2005 Dec 1;23(34):8802-11. doi: 10.1200/JCO.2005.02.1287.

  PMID: 16314640 RESULT

• Vasey PA, Jayson GC, Gordon A, Gabra H, Coleman R, Atkinson R, Parkin D, Paul J, Hay A, Kaye SB; Scottish Gynaecological Cancer Trials Group. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004 Nov 17;96(22):1682-91. doi: 10.1093/jnci/djh323.

  PMID: 15547181 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Docetaxel; Paclitaxel; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Paul A. Vasey, MD

  University of Glasgow

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 3, 2004
• Study Start: October 1, 1998
• Study Completion: December 1, 2004
• Last Updated: December 19, 2013

Record last verified: 2007-10

Locations

GB (1)