Recurrent, Persistent or Metastasized Cervical CancerPhase 3AGO-Zervix-1NCT01405235
Study on Paclitaxel Plus Topotecan in Comparison With Topotecan Plus Cisplatin in Recurrent or Persistent Cervical Carcinoma
A Phase 3 study testing Paclitaxel and Cisplatin/Paclitaxel in people with Recurrent, Persistent or Metastasized Cervical Cancer, run by Institut fuer Frauengesundheit at 1 site in Germany.
Trial summary
Current planning for studies involving patients with recurrent, persistent, or metastasized cervical cancer must take into consideration that up to 75% of all patients are assumed to have already been treated with cisplatin in conjunction with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent, Persistent or Metastasized Cervical Cancer
- What is being tested?
- Paclitaxel and Cisplatin/Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients must display the following:
- Sufficient hematologic function: absolute neutrophil count ≥ 1.
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Current planning for studies involving patients with recurrent, persistent, or metastasized cervical cancer must take into consideration that up to 75% of all patients are assumed to have already been treated with cisplatin in conjunction with radiation therapy. It seems questionable to continue to treat patients with cisplatin when cancer has recurred. Thus, it is important to seek alternative active combinations. The studies GOG 169 and 179 demonstrated that a combination of paclitaxel and cisplatin was superior to a cisplatin monotherapy with respect to therapeutic response and progression-free survival, as was a combination of topotecan and cisplatin with respect to therapeutic response, progression-free survival, and total survival. To achieve further improvement in total survival and to answer questions regarding the value of using a platinum-free combination, we propose that a study should be conducted to compare the efficacy of a platinum-free combination of paclitaxel and topotecan to a combination of cisplatin and topotecan.
Read the detailed description
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.
- Being tested
- Paclitaxel, Cisplatin/Paclitaxel
- Keywords
- Paclitaxel/Topotecan, Cisplatin/Topotecan
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
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
Cisplatin/PaclitaxelDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm B: Cisplatin/Topotecane | Active comparator | 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 Receives: Drug: Cisplatin/Paclitaxel |
| Arm A: Paclitaxel/Topotecan | Experimental | 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 Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in target lesion according to RECIST 1.0
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startSep 2006
- Primary completionJun 2012 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent, Persistent or Metastasized Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Schantl Pharma Service, Germany
- Investigators
- Falk Thiel, Dr. med., Study chair, Frauenklinik Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405235
- Sponsor's protocol ID
- IFG-01-0106
- Acronym
- AGO-Zervix-1
- Status last verified
- Sep 2006
- First submitted
- 27 Jul 2011
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gass P, Thiel FC, Haberle L, Ackermann S, Theuser AK, Hummel N, Boehm S, Kimmig R, Reinthaller A, Becker S, Hilpert F, Janni W, Vergote I, Harter P, Emons J, Hein A, Beckmann MW, Fasching PA, Poschke P; AGO Uterus Commission. Primary results of the AGO-Zervix-1 Study: A prospective, randomized phase III study to compare the effects of paclitaxel and topotecan with those of cisplatin and topotecan in the treatment of patients with recurrent and persistent cervical cancer. Gynecol Oncol. 2024 Apr;183:25-32. doi: 10.1016/j.ygyno.2024.03.002. Epub 2024 Mar 14.
PubMed 38490057
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01405235
- Acronym / sponsor ID
- AGO-Zervix-1 / IFG-01-0106
- Keywords
- Paclitaxel/Topotecan, Cisplatin/Topotecan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Schantl Pharma Service, Germany
- Study start
- Sep 2006
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current planning for studies involving patients with recurrent, persistent, or metastasized cervical cancer must take into consideration that up to 75% of all patients are assumed to have already been treated with cisplatin in conjunction with radiation therapy. It seems questionable to continue to treat patients with cisplatin when cancer has recurred. Thus, it is important to seek alternative active combinations. The studies GOG 169 and 179 demonstrated that a combination of paclitaxel and cisplatin was superior to a cisplatin monotherapy with respect to therapeutic response and progression-free survival, as was a combination of topotecan and cisplatin with respect to therapeutic response, progression-free survival, and total survival. To achieve further improvement in total survival and to answer questions regarding the value of using a platinum-free combination, we propose that a study should be conducted to compare the efficacy of a platinum-free combination of paclitaxel and topotecan to a combination of cisplatin and topotecan.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B: Cisplatin/Topotecane | Active comparator | Drug: Cisplatin/PaclitaxelTopotecan 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 |
| Arm A: Paclitaxel/Topotecan | Experimental | Drug: PaclitaxelPaclitaxel 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Patients must display the following:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelPaclitaxel 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 | Drug | Arm A: Paclitaxel/Topotecan |
| Cisplatin/PaclitaxelTopotecan 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 | Drug | Arm B: Cisplatin/Topotecane |
Primary outcome
Changes in target lesion according to RECIST 1.0
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
- Derived from this study: PubMed 38490057Gass P, Thiel FC, Haberle L, Ackermann S, Theuser AK, Hummel N, Boehm S, Kimmig R, Reinthaller A, Becker S, Hilpert F, Janni W, Vergote I, Harter P, Emons J, Hein A, Beckmann MW, Fasching PA, Poschke P; AGO Uterus Commission. Primary results of the AGO-Zervix-1 Study: A prospective, randomized phase III study to compare the effects of paclitaxel and topotecan with those of cisplatin and topotecan in the treatment of patients with recurrent and persistent cervical cancer. Gynecol Oncol. 2024 Apr;183:25-32. doi: 10.1016/j.ygyno.2024.03.002. Epub 2024 Mar 14.
Related trials for Recurrent, Persistent or Metastasized Cervical Cancer
RecruitingPhase 2
Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer
Cervical Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Falk Thiel, Dr. med. study chair
Frauenklinik Universitätsklinikum Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel and Cisplatin/Paclitaxel in people with Recurrent, Persistent or Metastasized Cervical Cancer, run by Institut fuer Frauengesundheit at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in target lesion according to RECIST 1.0 (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01405235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.