Recurrent Ovarian Epithelial Cancer
Conditions
Brief summary
This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES: I. Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with oxaliplatin and topotecan. II. Determine the toxic effects in patients treated with this regimen. SECONDARY OBJECTIVES: I. Estimate the time to progression and overall clinical response duration in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to response to prior platinum therapy (resistant vs sensitive). Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
Interventions
DRUGoxaliplatin
Given IV
DRUGtopotecan
Given IV
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer * Meets 1 of the following criteria for response to prior platinum-based therapy: * Platinum-resistant disease, defined as a disease-free interval of \< 6 months after prior platinum-based therapy OR progressive disease on a platinum-containing regimen * Platinum-sensitive disease, defined as a disease-free interval of \> 6 months after prior platinum-based therapy * Measurable or evaluable disease: Measurable disease is characterized as lesions reproducibly measurable in 1 dimension; evaluable disease is defined as known disease with CA125 levels \> 50 U/mL on 2 occasions \>= 1 week apart * Previously treated with a taxane and platinum-based regimen, only 1 prior platinum-based regimen, including IV or intraperitoneal consolidation, one additional non-platinum and non-topotecan chemotherapy regimen allowed * Life expectancy \>= 4 months * Total bilirubin =\< 1.5 times upper limit of normal (ULN) * AST =\< 2.5 times ULN (5 times ULN if liver metastases are present) * Creatinine =\< 1.5 times ULN AND creatinine clearance \> 40 mg/dL
Exclusion criteria
* No presence of any other active cancer * No uncontrolled intercurrent illness, including the following: * Infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No history of severe allergy to platinum compounds * (Mild reaction (skin only) allowed provided a negative skin test is obtained) * No history of allergic reaction to appropriate antiemetics (e.g., 5HT3 antagonists) * Recovered from prior chemotherapy * At least 2 weeks since prior radiotherapy and recovered * At least 4 weeks since prior investigational drugs * No prior radiotherapy to the whole pelvic field * No unresolved sequelae resulting from any surgical procedures * No concurrent colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) during topotecan infusion * No concurrent participation in another investigational trial * No other concurrent investigational agents * No other concurrent anticancer therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Every two cycles for up to 24 weeks. | Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression by RECIST and/or CA 125 | Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks | Time to disease progression by RECIST and/or CA 125 |
Countries
United States
Participant flow
Recruitment details
A total of 39 patients were enrolled from 3 institutions between January 2006 and October 2009
Pre-assignment details
1 patient never received treatment
Participants by arm
| Arm | Count |
|---|---|
| Treatment Stratum I: (Oxaliplatin Plus Topotecan) Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV | 19 |
| Treatment Stratum II (Oxaliplatin Plus Topotecan) Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
oxaliplatin: Given IV
topotecan: Given IV | 20 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient never received treatment | 0 | 1 |
Baseline characteristics
| Characteristic | Treatment Stratum I: (Oxaliplatin Plus Topotecan) | Treatment Stratum II (Oxaliplatin Plus Topotecan) | Total |
|---|---|---|---|
| Age, Continuous | 61 years | 59 years | 60 years |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 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 | — / — | — / — |
| other Total, other adverse events | 18 / 19 | 18 / 19 |
| serious Total, serious adverse events | 14 / 19 | 12 / 19 |
Outcome results
Primary
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.
Time frame: Every two cycles for up to 24 weeks.
Population: 30 patients were analyzed. Eight patients discontinued treatment before 2 cycles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Stratum I (Oxaliplatin Plus Topotecan) | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Complete Response | 3 participants |
| Treatment Stratum I (Oxaliplatin Plus Topotecan) | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Partial Response | 1 participants |
| Treatment Stratum I (Oxaliplatin Plus Topotecan) | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Stable Disease | 8 participants |
| Treatment Stratum I (Oxaliplatin Plus Topotecan) | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Disease Progression | 4 participants |
| Treatment Stratum II (Oxaliplatin Plus Topotecan) | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Disease Progression | 1 participants |
| Treatment Stratum II (Oxaliplatin Plus Topotecan) | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Complete Response | 3 participants |
| Treatment Stratum II (Oxaliplatin Plus Topotecan) | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Stable Disease | 4 participants |
| Treatment Stratum II (Oxaliplatin Plus Topotecan) | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Partial Response | 6 participants |
Secondary
Time to Disease Progression by RECIST and/or CA 125
Time to disease progression by RECIST and/or CA 125
Time frame: Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Stratum I (Oxaliplatin Plus Topotecan) | Time to Disease Progression by RECIST and/or CA 125 | 6.3 months |
| Treatment Stratum II (Oxaliplatin Plus Topotecan) | Time to Disease Progression by RECIST and/or CA 125 | 12.6 months |