Study on Paclitaxel Plus Topotecan in Comparison With Topotecan Plus Cisplatin in Recurrent or Persistent Cervical Carcinoma (AGO-Zervix-1)
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ClinicalTrials.gov Identifier: NCT01405235 |
Recruitment Status : Unknown
Verified September 2006 by Institut fuer Frauengesundheit.
Recruitment status was: Active, not recruiting
First Posted : July 29, 2011
Last Update Posted : April 12, 2012
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Condition or disease | Intervention/treatment | Phase |
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Recurrent, Persistent or Metastasized Cervical Cancer | Drug: Paclitaxel Drug: Cisplatin/Paclitaxel | Phase 3 |
Design: This will be a prospective, randomized, multicenter, non-blinded phase III A study.
Dosages: Arm A Paclitaxel 70 mg/m2/d i.v. on Days 1, 8, and 15 in combination with Topotecan 1.75 mg/m2/d i.v. on Days 1, 8, and 15, q 28 d Arm B Topotecan 0.75 mg/m2/d i.v. on Days 1- 3 in combination with Cisplatin 50 mg/m2 i.v. on Day 1, q 21 d Duration of Therapy: Each patient will participate in the study until a maximum of six cycles have been completed, or until there is evidence of disease progression, or until toxicity prevents further therapy. Patients with continued response or stable disease may continue to participate in the study for an additional 3 cycles beyond the original 6 cycles with consent of the Study Director, but this must be documented in the CRF.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 312 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2006 |
Estimated Primary Completion Date : | June 2012 |
Estimated Study Completion Date : | January 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Arm B: Cisplatin/Topotecane
Topotecan 0.75 mg/m2/d i.v. on Days 1- 3 in combination with Cisplatin 50 mg/m2 i.v. on Day 1, q 21 d
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Drug: Cisplatin/Paclitaxel
Topotecan 0.75 mg/m2/d i.v. on Days 1- 3 in combination with Cisplatin 50 mg/m2 i.v. on Day 1, q 21 d |
Experimental: Arm A: Paclitaxel/Topotecan
Paclitaxel 70 mg/m2/d i.v. on Days 1, 8, and 15 in combination with Topotecan 1.75 mg/m2/d i.v. on Days 1, 8, and 15, q 28 d
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Drug: Paclitaxel
Paclitaxel 70 mg/m2/d i.v. on Days 1, 8, and 15 in combination with Topotecan 1.75 mg/m2/d i.v. on Days 1, 8, and 15, q 28 d |
- Changes in target lesion according to RECIST 1.0 [ Time Frame: week 12 ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 radiochemotherapy.
- 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.
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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 normal.
- 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.
Exclusion Criteria:
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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 skin cancer.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405235
Germany | |
Universitätsfrauenklinik | |
Erlangen, Bavaria, Germany, 91054 |
Study Chair: | Falk Thiel, Dr. med. | Frauenklinik Universitätsklinikum Erlangen |
Responsible Party: | Frau Dr. med. Patricia Oppelt, Institut fuer Frauengesundheit GmbH |
ClinicalTrials.gov Identifier: | NCT01405235 |
Other Study ID Numbers: |
IFG-01-0106 |
First Posted: | July 29, 2011 Key Record Dates |
Last Update Posted: | April 12, 2012 |
Last Verified: | September 2006 |
Paclitaxel/Topotecan Cisplatin/Topotecan |
Uterine Cervical Neoplasms Recurrence Disease Attributes Pathologic Processes Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |