Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	GOG-0204 NCT00064077

Objectives

1. Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
2. Compare the toxic effects of these regimens in these patients.
3. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  • Stage IVB, recurrent, or persistent disease
• Not amenable to curative surgery and/or radiotherapy
• At least 1 unidimensionally measurable lesion
  • At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
  • Biopsy confirmation required if lesion is less than 30 mm
  • Target lesion must be outside of a previously irradiated field
• No craniospinal metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent cytokines

Chemotherapy

• At least 6 weeks since prior chemoradiotherapy and recovered
• No prior chemotherapy (except when concurrently administered with radiotherapy)

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• See Chemotherapy
• At least 3 weeks since prior radiotherapy and recovered

Surgery

• Recovered from prior surgery

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-1

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 1.5 times normal
• Alkaline phosphatase no greater than 3 times normal
• AST no greater than 3 times normal

Renal

• Creatinine ≤ 1.2 mg/dL

  OR

• Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min
• No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
• No prior malignancy whose treatment contraindicates the current study therapy
• No concurrent clinically significant infection

Expected Enrollment

A total of 600 patients (150 per treatment arm) will be accrued for this study within 4 years.

Outcomes

Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale at baseline, courses 2 and 5, and 9 months after completion of study treatment

Brief Pain Inventory

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
• Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
• Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
• Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Monk BJ, Sill MW, McMeekin DS, et al.: Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol 27 (28): 4649-55, 2009.[PUBMED Abstract]

Monk BJ, Sill M, McMeekin DS, et al.: A randomized phase III trial of four cisplatin (CIS) containing doublet combinations in stage IVB, recurrent or persistent cervical carcinoma: a Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5504, 2008.

Wenzel LB, Huang H, Cella D, et al.: Quality-of-life results of a randomized phase III trial of four cisplatin (Cis) containing doublet combinations in stage IVB cervical carcinoma: A gynecologic oncology group (GOG) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-5529, 2008.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Bradley Monk, MD, Protocol chair		Ph: 714-456-7974 Email: bjmonk@uci.edu

Registry Information
Official Title		A Randomized Phase III Trial Of Paclitaxel plus Cisplatin versus Vinorelbine plus Cisplatin versus Gemcitabine plus Cisplatin versus Topotecan plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix
Trial Start Date		2003-07-23
Registered in ClinicalTrials.gov		NCT00064077
Date Submitted to PDQ		2003-05-19
Information Last Verified		2007-04-30
NCI Grant/Contract Number		CA27469

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