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Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
vinorelbine tartrate
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven advanced, persistent, or recurrent squamous cell carcinoma of the cervix that failed local therapy and is considered incurable Bidimensionally measurable abdominal, pelvic, or other lesion by palpation, x- ray, or ultrasound If sole site of measurable disease previously irradiated, then documented disease progression at that site required PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Karnofsky 60%-100% Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 50 mL/min if creatinine greater than 1.2 mg/dL Other: No clinically significant infection No preexisting, clinically significant peripheral neuropathy unless due to cancer No other prior or concurrent malignancy except nonmelanomatous skin cancer No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except for radiosensitization Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Recovered from the toxic effects of any recent radiotherapy Surgery: Recovered from the toxic effects of any recent surgery

Sites / Locations

  • Chao Family Comprehensive Cancer Center
  • MBCCOP - Hawaii
  • Johns Hopkins Oncology Center
  • CCOP - Ann Arbor Regional
  • Cancer Center of Albany Medical Center
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • CCOP - Upstate Carolina
  • Brookview Research, Inc.
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 24, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002813
Brief Title
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer
Official Title
A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.
Detailed Description
OBJECTIVES: I. Determine the activity of cisplatin and vinorelbine in terms of response rate, duration of response, time to treatment failure, and survival in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. OUTLINE: This is a multicenter study. Patients receive vinorelbine IV over 6-10 minutes on days 1, 8, 15, and 22 and cisplatin IV over 4 hours beginning after completion of vinorelbine infusion on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within approximately 20 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven advanced, persistent, or recurrent squamous cell carcinoma of the cervix that failed local therapy and is considered incurable Bidimensionally measurable abdominal, pelvic, or other lesion by palpation, x- ray, or ultrasound If sole site of measurable disease previously irradiated, then documented disease progression at that site required PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Karnofsky 60%-100% Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 50 mL/min if creatinine greater than 1.2 mg/dL Other: No clinically significant infection No preexisting, clinically significant peripheral neuropathy unless due to cancer No other prior or concurrent malignancy except nonmelanomatous skin cancer No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except for radiosensitization Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Recovered from the toxic effects of any recent radiotherapy Surgery: Recovered from the toxic effects of any recent surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Morris, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
MBCCOP - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Cancer Center of Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15310778
Citation
Morris M, Blessing JA, Monk BJ, McGehee R, Moore DH. Phase II study of cisplatin and vinorelbine in squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004 Aug 15;22(16):3340-4. doi: 10.1200/JCO.2004.12.006.
Results Reference
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Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer

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