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Sequential Chemotherapy in Treating Patients With Residual Disease Following Surgery for Stage IIB, Stage III, or Stage IV Ovarian Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: SmithKline Beecham
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003733
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of sequential chemotherapy in treating patients with residual disease following surgery for stage IIB, stage III, or stage IV ovarian cancer.


Condition Intervention Phase
Ovarian Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: topotecan hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   Carboplatin    Paclitaxel    Topotecan hydrochloride    Topotecan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of Sequential Carboplatin, Paclitaxel and Hycamtin in Patients With Previously Untreated Advanced Ovarian Cancer

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

Estimated Enrollment:   40
Study Start Date:   December 1997

Detailed Description:

OBJECTIVES: I. Evaluate the efficacy of sequential carboplatin, paclitaxel, and topotecan in terms of disease response, time to progression, survival and progression free survival in patients with stage IIB, stage III, or stage IV ovarian epithelial cancer. II. Assess the toxicity of this regimen in this patient population.

OUTLINE: Patients receive carboplatin IV over 30 to 60 minutes on days 1 and 22. Patients then receive paclitaxel IV over 3 hours on days 43 and 64, then topotecan IV over 30 minutes daily for 5 days beginning on days 85, 106, 127, and 148. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 40 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 confirmed advanced ovarian epithelial carcinoma with greater than 1 cm residual disease at completion of initial surgery Stage IIB, IIIA, IIIB, IIIC, or IV Measurable disease OR CA 125 greater than 120 units/mL obtained post surgery

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: Biological therapy: No prior or concurrent immunotherapy Chemotherapy: No prior or concurrent chemotherapy Endocrine: No prior or concurrent hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy except to limited fields (e.g., for palliation of bone pain) Surgery: Diagnostic surgery performed less than 12 weeks prior to study No concurrent interval debulking Other: At least 30 days or five half-lives since any prior investigational therapy No other concurrent investigational therapy --Patients Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 4,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 5 times ULN if liver and/or bone metastases present) Renal: Creatine less than 2 times ULN Creatinine clearance at least 50 mL/min Other: No prior malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix No uncontrolled infection No other concurrent medical conditions that would prevent full compliance or expose patient to extreme risk or decreased life expectancy No concurrent medical condition for which treament with platinum compounds is contraindicated No history of allergy to compounds related to the drugs used in this study No prior motor or sensory neurotoxicity grade 2 or worse Not pregnant or nursing Fertile patients must use effective contraception

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003733

Locations
United Kingdom, England
Charing Cross Hospital    
      London, England, United Kingdom, W6 8RF
Mount Vernon Hospital    
      Northwood, England, United Kingdom, HA6 2RN

Sponsors and Collaborators
SmithKline Beecham

Investigators
Study Chair:     Gordon J.S. Rustin, MD     Mount Vernon Cancer Centre at Mount Vernon Hospital    
  More Information


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

Publications of Results:
Guppy AE, Nelstrop A, Agarwal R, et al.: A phase II study of sequential carboplatin, paclitaxel and topotecan in patients with previously untreated advanced ovarian cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-872, 2002.
 
Agarwal R, Serkl MJ, Nelstrop A, et al.: A phase II study of sequential carboplatin, paclitaxel and topotecan in patients with previously untreated advanced ovarian cancer. Br J Cancer 80(supp 2): A107, 1999.
 

Study ID Numbers:   CDR0000066848, SB-104864/289, EU-98068
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003733
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II ovarian epithelial cancer  
stage III ovarian epithelial cancer  
stage IV ovarian epithelial cancer  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Carboplatin
Ovarian epithelial cancer
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Topotecan
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Enzyme Inhibitors
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on September 16, 2008




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