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Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00276796
First received: January 12, 2006
Last updated: May 24, 2013
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Drug: cisplatin
Drug: paclitaxel
Drug: topotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Limited Access Phase II Trial of Weekly Topotecan (NSC #609699), Paclitaxel (NSC #673089), and Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • The frequency and duration of objective response [ Designated as safety issue: No ]
  • The frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival and overall survival [ Designated as safety issue: No ]
  • Prognostic factor: prior chemoradiation [ Designated as safety issue: No ]

Estimated Enrollment: 66
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Estimate the antitumor activity of the combination of paclitaxel, topotecan, and cisplatin in patients with advanced, persistent, or recurrent carcinoma of the cervix.
  • Determine the nature and degree of toxicity for this drug regimen in these patients.

Secondary

  • Determine the duration of progression-free survival and overall survival.
  • Determine the impact of prior chemoradiation on response to treatment.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276796

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Harry J. Long, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00276796     History of Changes
Other Study ID Numbers: CDR0000456248, GOG-0076EE
Study First Received: January 12, 2006
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
cervical squamous cell carcinoma
stage III cervical cancer
recurrent cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical small cell carcinoma
stage IVA cervical cancer
stage IVB cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Cisplatin
Paclitaxel
Topotecan
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014