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
Overview
- Phase
- Phase 3
- Intervention
- Cisplatin
- Conditions
- Cervical Adenocarcinoma
- Sponsor
- Gynecologic Oncology Group
- Enrollment
- 513
- Locations
- 1
- Primary Endpoint
- Duration of Overall Survival (OS)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.
Detailed Description
PRIMARY OBJECTIVES: I. 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. II. Compare the toxic effects of these regimens in these patients. III. Compare the quality of life of patients treated with these regimens. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Performance status - GOG 0-1
- •Absolute neutrophil count at least 1,500/mm\^3
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I (paclitaxel, cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
Intervention: Cisplatin
Arm I (paclitaxel, cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
Intervention: Paclitaxel
Arm I (paclitaxel, cisplatin)
Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
Intervention: Quality-of-Life Assessment
Arm II (vinorelbine, cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
Intervention: Cisplatin
Arm II (vinorelbine, cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
Intervention: Quality-of-Life Assessment
Arm II (vinorelbine, cisplatin)
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
Intervention: Vinorelbine Tartrate
Arm III (gemcitabine, cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
Intervention: Cisplatin
Arm III (gemcitabine, cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
Intervention: Gemcitabine Hydrochloride
Arm III (gemcitabine, cisplatin)
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
Intervention: Quality-of-Life Assessment
Arm IV (topotecan, cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
Intervention: Cisplatin
Arm IV (topotecan, cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
Intervention: Quality-of-Life Assessment
Arm IV (topotecan, cisplatin)
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
Intervention: Topotecan Hydrochloride
Outcomes
Primary Outcomes
Duration of Overall Survival (OS)
Time Frame: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Secondary Outcomes
- Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)(Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1)
- Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).(Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1)
- Frequency of Response Using RECIST Version 1.0(Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years))
- Duration of Progression-free Survival (PFS)(Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years))
- Pain, Assessed by Brief Pain Inventory(Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1)