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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276796
• Other study ID #: CDR0000456248
• Secondary ID: GOG-0076EE
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: May 24, 2013

Study information

• Verified date: February 2009
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• cisplatin

• paclitaxel

• topotecan hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency and duration of objective response			No
Primary	The frequency and severity of observed adverse effects			Yes
Secondary	Progression-free survival and overall survival			No
Secondary	Prognostic factor: prior chemoradiation			No