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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

Phase 2
18 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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

- Each lesion must be ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT

- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The frequency and duration of objective response

Safety Issue:


Principal Investigator

Harry J. Long, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms