A Prospective, Randomized Phase III Study to Compare the Effects of Paclitaxel and Topotecan to Those of Cisplatin and Topotecan for Treatment of Patients With Recurrent and Persistent Cervical Cancer
- Patients must have a histologically confirmed recurrent, persistent, or metastasized
squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix,
for which a curative treatment by operation and/or radiation therapy is not possible.
- Patients must have been previously treated with cisplatin in the context of
- All patients must present with measurable disease. Measurable disease is defined as a
minimum of one lesion that can be accurately measured in at least one dimension
(longest dimension to be recorded). Each lesion must measure ≥ 20 mm when measured by
conventional techniques, including palpation, x-ray, CT, and MRI, or ≥ 10 mm when
measured by spiral CT. Patients must have at least one "target lesion" that can be
used to evaluate response according to RECIST criteria during this study.
- When a biopsy is performed, it should be performed on this lesion. A lesion outside
of the irradiated area should ideally be selected as the "target lesion" on patients
who have tumors both inside and outside a previously irradiated area. A previously
irradiated lesion may only be considered as a "target lesion" if, after the radiation
therapy had been completed, this lesion objectively led to a diagnosis of recurrence,
or progress specific to this lesion was observed.
- Patients must display the following:
- Sufficient hematologic function: absolute neutrophil count ≥ 1.
- 500/μl; granulocytes > 3,000/μl; thrombocytes ≥ 100,000/μl.
- Sufficient renal function: serum creatinine ≤ 1.2 mg/dl. In patients with a
serum A prospective, randomized phase III study to compare the effects of
Paclitaxel and Topotecan to those of Cisplatin and Topotecan for treatment of
patients with recurrent or persistent cervical cancer Page 24 Study Protocol
Version 1.1 dated 09/25/2006 creatinine of > 1.2 mg/dl, the results of a 24-hour
creatinine clearance must yield a level > 50 cm3/min for eligibility.
- Sufficient liver function: bilirubin ≤ 1.5 times the institutional upper limit
of normal, GOT, alkaline phosphatase ≤ 3 times the institutional upper limit of
- Patients must display an ECOG performance status of 0-2 (Karnofsky > 60%).
- Patients must have recovered from the aftereffects of any surgery, radiation
therapy, or chemotherapy. A minimum of six weeks must have passed since the last
administration of chemotherapy, and at least three weeks must have passed since
the last treatment with radiation alone.
- Patients must have signed an official consent document which also authorizes the
release of personal health information. Patients unable to give their consent
independently may not participate in the study.
- Patients must fulfill all the requirements defined in Section 8.1, including
completion of a baseline quality of life questionnaire, prior to their inclusion
in the study.
- Patients must be free of clinically significant infection.
- Patients must be 18 years of age or older.
- Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents
or percutaneous drainage. Patients with a serum creatinine > 1.2 mg/dl but < 1.5
mg/dl and a 24-hour creatinine clearance result of < 50 cm3/min. Patients with a
serum creatinine ≥ 1.5 mg/dl. A prospective, randomized phase III study to compare
the effects of Paclitaxel and Topotecan to those of Cisplatin and Topotecan for
treatment of patients with recurrent or persistent cervical cancer Study Protocol
Version 1.1 dated 09/25/2006 Page 25
- Patients who have received prior chemotherapy, unless the chemotherapy was
administered with concomitant radiation therapy.
- Patients who are pregnant or lactating.
- Patients with craniospinal metastases.
- Patients with a concomitant malignant disease, with the exception of nonmelanoma
- Patients with a previous invasive malignant disease (other than nonmelanoma skin
cancer) showing evidence of this disease within the last 5 years, or for whom
the therapy to be administered during this study is contraindicated due to
previous treatment received for this malignant disease.
- Patients who are participating in another clinical study at the same time or who
will have done so up to 30 days before the planned end of this study.