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Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer

This study has been completed.

Sponsored by: Schering-Plough
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003880
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill more tumor cells.

PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III ovarian or stage III primary peritoneal cancer with residual disease following surgery to remove the tumor.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: recombinant adenovirus-p53 SCH-58500
Phase II
Phase III

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   Carboplatin    Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   A Phase II/III Trial of Chemotherapy Alone Versus Chemotherapy Plus SCH 58500 in Newly Diagnosed Stage III Ovarian and Primary Peritoneal Cancer Patients With Greater Than or Equal to 0.5 cm and Less Than or Equal to 2 cm Residual Disease Following Surgery

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

Study Start Date:   February 1999

Detailed Description:

OBJECTIVES: I. Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on progression free survival, overall survival, safety, response, and CA-125 levels in patients with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer.

OUTLINE: This is a randomized, open label, multicenter study. Patients receive treatment of IV paclitaxel and IV carboplatin. Patients are randomized to one of two treatment groups: Arm I: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Courses are repeated every 21 days. Arm II: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Patients receive intraperitoneal SCH 58500 on days 1-5. Courses are repeated every 21 days. Patients are followed every 6 weeks for 36 months, then every 3 months for 2 years, and then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) 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 stage III ovarian epithelial or primary peritoneal cancer with residual disease no greater than 2 cm following cytoreductive surgery The following cell types are eligible: Serous adenocarcinoma, mucinous adenocarcinoma, clear cell adenocarcinoma, transitional cell, adenocarcinoma NOS, endometrioid adenocarcinoma, mixed epithelial carcinoma, or peritoneal serous papillary carcinoma Total abdominal hysterectomy with salpingo-oophorectomy or supracervical hysterectomy, omentectomy, tumor reduction, lymph node assessment, and debulking if nodes 2 cm or greater No endometrial malignancy treated with supracervical hysterectomy No cytologically positive pleural effusion No tumors of borderline histology No cancer of the fallopian tubes

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% 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 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2 mg/dL Glomerular filtration rate no less than 30 Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No other serious medical condition No other prior malignancies except carcinoma in situ of the cervix, nonmelanomatous skin cancer, Dukes A colorectal cancer from which patient has been disease free for past 5 years, or stage I or II breast cancer from which patient has been disease free for past 10 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent cytokine therapy allowed Chemotherapy: No more than 1 prior chemotherapy course for ovarian or peritoneal cancer At least 10 years since prior adjuvant chemotherapy for breast cancer Endocrine therapy: At least 3 months since prior systemic corticosteroid or other immunosuppressive therapy Concurrent female hormonal replacement allowed Radiotherapy: No prior radiotherapy for ovarian or peritoneal cancer No prior radiotherapy to abdomen Surgery: Prior surgery allowed Other: No other concurrent investigational drugs

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003880

Show 44 study locations  Show 44 Study Locations

Sponsors and Collaborators
Schering-Plough

Investigators
Study Chair:     Jo Ann Horowitz, MD     Schering-Plough    
  More Information

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

Study ID Numbers:   CDR0000067047, SPRI-C/I98-102, SPRI-C98-102, NCI-V99-1544
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003880
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer  
ovarian mixed epithelial carcinoma  
ovarian serous cystadenocarcinoma  
ovarian mucinous cystadenocarcinoma  
ovarian endometrioid adenocarcinoma
ovarian clear cell cystadenocarcinoma
peritoneal cavity cancer

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

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

ClinicalTrials.gov processed this record on September 05, 2008




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