NCT00276796

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

May 27, 2013

Status Verified

February 1, 2009

First QC Date

January 12, 2006

Last Update Submit

May 24, 2013

Conditions

Cervical Cancer

Keywords

cervical squamous cell carcinomastage III cervical cancerrecurrent cervical cancercervical adenocarcinomacervical adenosquamous cell carcinomacervical small cell carcinomastage IVA cervical cancerstage IVB cervical cancer

Outcome Measures

Primary Outcomes (2)

  • The frequency and duration of objective response

  • The frequency and severity of observed adverse effects

Secondary Outcomes (2)

  • Progression-free survival and overall survival

  • Prognostic factor: prior chemoradiation

Interventions

cisplatinDRUG
paclitaxelDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Advanced, persistent, or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression * Histologic confirmation of the original primary tumor is required * Disease must be measurable in at least one dimension by conventional techniques, including palpation, plain x-ray, CT scan, or MRI * Measurable disease is defined as at least one lesion that can be accurately measured * Each lesion must be ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiation therapy 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 * Nonmelanoma skin cancer allowed * 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 * Prior cisplatin as a radiosensitizer for primary treatment of disease allowed * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CisplatinPaclitaxelTopotecan

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Harry J. Long, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Primary Completion

January 1, 2007

Last Updated

May 27, 2013

Record last verified: 2009-02