Ovarian Cancer
Conditions
Keywords
platin-resistant
Brief summary
Compatibility of the topotecan therapy in combination with carboplatin.
Detailed description
The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.
Interventions
DRUGHycamtin
Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d
Sponsors
North Eastern German Society of Gynaecological Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years * patient with ovarian cancer after primary therapy * bone marrow function leukocytes \>= 4,0 x 109/ l, platelets \>= 100 109/l, hemoglobin \>= 9 g/dl * renal function creatinin \<= 1,5 mg% or creatinin clearance \>= 60 ml/min * liver function bilirubin \<= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range * ECOG \<= 2 * Intention of regular follow-up visits for the duration of the study * written informed consent
Exclusion criteria
* any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol * ECOG \> 2 * patients with radiotherapy within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of a DLT (Dose Limiting Toxicity) | after each cycle for up to one year | A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | after every third cycle, for up to one year | Progression-free survival according to kaplan-meier-estimator |
Participant flow
Recruitment details
Recruitment period: 2.6.2004 - 30.8.2005
Pre-assignment details
2 patients missed the inclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| Relapse 6-12 Months dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0. | 13 |
| Relapse >12 Months dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)
If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application))
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0. | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Relapse >12 Months | Total | Relapse 6-12 Months |
|---|---|---|---|
| Age, Continuous | 63 years | 61.5 years | 60 years |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IA | 1 Participants | 1 Participants | 0 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IB | 0 Participants | 0 Participants | 0 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IC | 2 Participants | 2 Participants | 0 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIA | 0 Participants | 0 Participants | 0 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIB | 0 Participants | 0 Participants | 0 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIC | 1 Participants | 2 Participants | 1 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIIA | 0 Participants | 0 Participants | 0 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIIB | 0 Participants | 2 Participants | 2 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IIIC | 8 Participants | 16 Participants | 8 Participants |
| Classification of tumour (according to FIGO ovarian cancer staging) stage IV | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment Germany | 13 participants | 26 participants | 13 participants |
| Sex: Female, Male Female | 13 Participants | 26 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 13 | 4 / 13 |
| other Total, other adverse events | 10 / 13 | 7 / 13 |
| serious Total, serious adverse events | 6 / 13 | 6 / 13 |
Outcome results
Primary
Occurrence of a DLT (Dose Limiting Toxicity)
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
Time frame: after each cycle for up to one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relapse 6-12 Months | Occurrence of a DLT (Dose Limiting Toxicity) | 0 Participants |
| Relapse >12 Months | Occurrence of a DLT (Dose Limiting Toxicity) | 1 Participants |
Secondary
Progression-free Survival (PFS)
Progression-free survival according to kaplan-meier-estimator
Time frame: after every third cycle, for up to one year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Relapse 6-12 Months | Progression-free Survival (PFS) | 7.3 months |
| Relapse >12 Months | Progression-free Survival (PFS) | 8.4 months |