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Clinical Trials (PDQ®)

Phase III Randomized Comparison of CDDP vs CDDP/DBD vs CDDP/IFF with Mesna in Patients with Stage IVB, Recurrent, or Persistent Squamous Cell Carcinoma of the Cervix

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedany ageNCIGOG-110

Objectives

I.  Compare, in a randomized Phase III setting, response rate, duration of 
response, progression-free interval, and survival in patients with advanced 
squamous cell carcinoma of the cervix randomly assigned to treatment with 
cisplatin vs. cisplatin/mitolactol vs. cisplatin/ifosfamide/mesna.

II.  Compare the toxicities of these regimens in patients with advanced 
cervical cancer.

Entry Criteria

Disease Characteristics:


Histologically confirmed advanced (Stage IVB), recurrent,
or persistent squamous cell carcinoma of the cervix

Not suitable for curative surgery and/or radiotherapy

Measurable disease required, as defined by:

  Any lesion measurable by physical examination or chest x-ray

  Sharply defined lesion more than 3 cm on CT scan or biopsy-
     or cytology-confirmed lesions less than 3 cm on CT scan

  Measurement by ultrasound is not acceptable

No bilateral hydronephrosis


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior cytotoxic chemotherapy except as radiosensitizer

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 3 weeks since prior radiotherapy
  Recovery from effects of prior radiotherapy required

Surgery:
  Recovery from effects of prior surgery required


Patient Characteristics:


Age:
  Any age

Performance status:
  GOG 0-2 (Karnofsky 50-100%)

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no more than 1.5 x normal
  SGOT no more than 3 x normal
  Alkaline phosphatase no more than 3 x normal
     (unless elevations are caused by liver metastases)
  Albumin at least 3 g/dl

Renal:
  Creatinine within normal limits

Other:
  No second malignancy except nonmelanomatous skin cancer
  No clinically significant infections
  No pregnant or nursing women


Expected Enrollment

Up to 121 evaluable patients may be entered on each treatment arm at an 
anticipated accrual rate of 12 patients/month.  If, after 62 patients have 
been treated on each arm, the response rate on the DBD or IFF arm is not 
greater than on the CDDP alone arm, accrual to that combination will stop; if 
the response rate on the CDDP alone arm is equal to or greater than both 
combination arms, the study will be closed at that time.

Outline

Randomized study.

Arm I:  Single-Agent Chemotherapy.  Cisplatin, CDDP, NSC-119875.

Arm II:  2-Drug Combination Chemotherapy.  CDDP; Mitolactol, Dibromodulcitol, 
DBD, NSC-104800.

Arm III:  2-Drug Combination Chemotherapy with Urothelial Protection.  CDDP; 
Ifosfamide, IFF, NSC-109724; with Mercaptoethane sulfonate, Mesna, NSC-113891.

Published Results

Omura GA, Blessing J, Vaccarello L, et al.: A randomized trial of cisplatin (C) versus cisplatin + mitolactol (CM) versus cisplatin + ifosfamide (CIFX) in advanced squamous carcinoma of the cervix (SCC) by the Gynecologic Oncology Group (GOG). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-736, 267, 1995.

Related Publications

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]

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

George A. Omura, MD, Protocol chair
Ph: 205-444-4617

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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