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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0076EE |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with topotecan and cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive paclitaxel IV over 1 hour followed by topotecan IV over 30 minutes and cisplatin IV over 1 hour on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| paclitaxel | Drug | |||
| topotecan hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency and duration of objective response | ||
| The frequency and severity of observed adverse effects |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival and overall survival | ||
| Prognostic factor: prior chemoradiation |
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DISEASE CHARACTERISTICS:
Advanced, persistent, or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression
Disease must be measurable in at least one dimension by conventional techniques, including palpation, plain x-ray, CT scan, or MRI
PATIENT CHARACTERISTICS:
GOG performance status 0-2
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
SGOT and alkaline phosphatase ≤ 2.5 times ULN
Neuropathy (sensory and motor) ≤ grade 1
No active infection requiring antibiotics
No evidence of more than one malignancy present within the past 5 years
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
No prior therapy with cytotoxic drugs for advanced or recurrent cervical carcinoma
No previous cancer treatment that contraindicates study treatment
No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer
No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of cervical cancer
Recovered from effects of recent surgery, radiotherapy, or other therapy
At least 4 weeks since prior radiotherapy
More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and free of recurrent or metastatic disease
More than 3 years since prior adjuvant chemotherapy for localized breast cancer provided patient is free of recurrent or metastatic disease
No hormonal therapy directed at the malignant tumor within the past week
Concurrent hormone replacement therapy is permitted
No concurrent amifostine or other protective reagents
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| Name | Affiliation | Role |
|---|---|---|
| Harry J. Long, MD | Mayo Clinic | Study Chair |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |