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Clinical Trials (PDQ®)

  • First Published: 10/1/1997
  • Last Modified: 2/21/2012

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Clinical Trials (PDQ®)

Phase III Randomized Study of Cisplatin (CDDP) versus Cisplatin plus Paclitaxel (Taxol) in Recurrent, Refractory, or Stage IVB Squamous Cell Carcinoma of the Cervix

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Single-Drug Chemotherapy Versus Combination Chemotherapy in Patients With Recurrent or Refractory Cancer of the Cervix

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedNot specifiedNCIGOG-0169

Objectives

I. Determine whether paclitaxel plus cisplatin improves response rate in 
patients with recurrent, refractory, or stage IVB squamous cell carcinoma of 
the cervix compared to single agent cisplatin.

II. Determine whether paclitaxel plus cisplatin improves progression free 
interval and survival compared to single agent cisplatin in these patients.

III. Compare the toxic effects of these two regimens in these patients.

IV. Measure health related quality of life prior to and during systemic 
cytotoxic therapy in these patients.

V. Compare health related quality of life in these patients receiving 
paclitaxel plus cisplatin versus single agent cisplatin.

Entry Criteria

Disease Characteristics:


Histologically proven recurrent, refractory, and stage IVB squamous cell 
carcinoma of the cervix not amenable to curative treatment with surgery and/or 
radiation therapy

Must have measurable lesions by physical examination, radiography, computed 
tomography or magnetic resonance imaging (lesions at least 3 cm can be 
measured by CT or MRI scan without biopsy confirmation; smaller lesions must 
be pathologically or cytologically confirmed)
 
No craniospinal metastases
 

Prior/Concurrent Therapy:


Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy except when used for radiation sensitization
 At least 6 weeks since chemoradiotherapy and recovered

Endocrine therapy:
 Not specified

Radiotherapy:
 At least 3 weeks since radiation therapy and recovered
 At least 6 weeks since chemoradiotherapy and recovered
 No prior radiotherapy for other malignancies

Surgery:
 Prior surgery allowed and recovered


Patient Characteristics:


Age:
 Not specified
 
Performance Status:
 GOG 0-2

Life Expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count at least 4000/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin no greater than 1.5 times upper limit of normal (ULN)
 SGOT no greater than 3.0 times ULN
 Alkaline phosphatase no greater than 3.0 times ULN

Renal:
 Creatinine no greater than 2.0 mg/dL

Other:
 No clinically significant infection
 Not pregnant or nursing
 No concurrent malignancies other than nonmelanomatous skin cancer 
 No bilateral hydronephrosis that cannot be alleviated by ureteral stents or
  percutaneous drainage
 No prior malignancies within at least 5 years 

Expected Enrollment

An anticipated 238 patients will be accrued in this study.

Outline

This is a randomized study.

The study consists of two treatment arms:
 Arm I: Cisplatin is administered IV every 3 weeks for 6 courses 
 Arm II: Paclitaxel is administered IV over 24 hours plus IV cisplatin every 3
  weeks for 6 courses
 
Patients will be discontinued from treatment if disease progression or 
unacceptable toxic effects are observed. 

Patients will be followed every 3 months for the first 2 years, every 6 months 
for the next 3 years, and then annually until death.

Published Results

McQuellon RP, Thaler HT, Cella D, et al.: Quality of life (QOL) outcomes from a randomized trial of cisplatin versus cisplatin plus paclitaxel in advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol 101 (2): 296-304, 2006.[PUBMED Abstract]

Moore DH, Blessing JA, McQuellon RP, et al.: Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. J Clin Oncol 22 (15): 3113-9, 2004.[PUBMED Abstract]

Moore DH, McQuellon RP, Blessing JA, et al.: A randomized phase III study of cisplatin versus cisplatin plus paclitaxel in stage IVB, recurrent or persistent squamous cell carcinoma of the cervix. [Abstract] Society of Gynecologic Oncologists 2004 Annual Meeting on Women's Cancer, 7-11 February 2004, San Diego, California. A-348, 2004.

Related Publications

Chase DM, Huang HQ, Wenzel L, et al.: Quality of life and survival in advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol 125 (2): 315-9, 2012.[PUBMED Abstract]

Moore DH, Tian C, Monk BJ, et al.: Prognostic factors for response to cisplatin-based chemotherapy in advanced cervical carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol 116 (1): 44-9, 2010.[PUBMED Abstract]

Paton F, Paulden M, Saramago P, et al.: Topotecan for the treatment of recurrent and stage IVB carcinoma of the cervix. Health Technol Assess 14 (Suppl 1): 55-62, 2010.[PUBMED Abstract]

Plaxe SC, Brooks SE, Tian C, et al.: Influence of race on tolerance of platinum-based chemotherapy and clinical outcomes in women with advanced and recurrent cervical cancer: a pooled analysis of 3 Gynecologic Oncology Group studies. Am J Obstet Gynecol 199 (5): 539.e1-6, 2008.[PUBMED Abstract]

Moore DH, Tian C, Monk BJ, et al.: Factors predictive of response to cisplatin-based chemotherapy in stage IVB persistent or recurrent cervical carcinoma: a multivariate analysis of three Gynecologic Oncology Group trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-5534, 282s, 2007.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

David Moore, MD, Protocol chair (Contact information may not be current)
Ph: 317-278-4822; 888-600-4822

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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