Cervical Cancer
Conditions
Keywords
recurrent cervical cancer, cervical squamous cell carcinoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer.
Detailed description
OBJECTIVES: * Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix that failed higher priority treatment protocols. * Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient are followed for every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.
Interventions
DRUGtopotecan hydrochloride
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma of the cervix * Squamous cell or nonsquamous cell * Persistent or recurrent disease * Documented disease progression * Measurable disease * At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Tumors within a previously irradiated field are considered non-target lesions unless disease progression is documented or a biopsy is obtained to confirm persistent disease at least 90 days after completion of prior radiotherapy * Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or nonsquamous cell carcinoma of the cervix * Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen * Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * Sensory or motor neuropathy ≤ grade 1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following: * Monoclonal antibodies * Cytokines * Small-molecule inhibitors of signal transduction * At least 3 weeks since prior biologic or immunologic agents for cervical cancer * No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim * No concurrent prophylactic thrombopoietic agents Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy) * No prior topotecan Endocrine therapy * At least 1 week since prior hormonal therapy for cervical cancer * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy Surgery * Recovered from prior surgery Other * At least 3 weeks since other prior therapy for cervical cancer * No prior cancer therapy that would preclude study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years. | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. |
| Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up | All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event). |
Countries
United States
Participant flow
Recruitment details
This trial was opened to patient entry on January 3, 2005 and was closed to accrual on October 29, 2007.
Participants by arm
| Arm | Count |
|---|---|
| Topotecan Hydrochloride Topotecan hydrochloride 3.0 mg/m² IV over 30 minutes every 7 days for 21 days; 7 days off (cycle = 28 days) | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible - second primary | 1 |
| Overall Study | Never treated | 1 |
Baseline characteristics
| Characteristic | Topotecan Hydrochloride |
|---|---|
| Age, Customized 40-49 years | 10 participants |
| Age, Customized <40 years | 4 participants |
| Age, Customized 50-59 years | 8 participants |
| Age, Customized 60-69 years | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 25 |
| serious Total, serious adverse events | 9 / 25 |
Outcome results
Primary
Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event).
Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Population: Eligible and treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 24 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 19 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 24 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 22 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 19 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 9 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 8 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 24 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Transfusions | 24 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphopenia | 24 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 23 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 1 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 16 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 21 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 24 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alopecia | 17 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea/Vomiting | 13 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 22 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other gastrointestinal | 12 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 22 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genito urinary | 22 participants |
| Topotecan Hydrochloride | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 6 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genito urinary | 2 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 3 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 3 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 5 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 0 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other gastrointestinal | 4 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 1 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 4 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 4 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 0 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alopecia | 7 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 8 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphopenia | 0 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 2 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Transfusions | 0 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea/Vomiting | 7 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 2 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 4 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 3 participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 4 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genito urinary | 1 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 9 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 3 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 4 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Transfusions | 0 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 12 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 0 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea/Vomiting | 4 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other gastrointestinal | 6 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 2 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 1 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 0 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 0 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 7 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 1 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 0 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alopecia | 1 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 1 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 0 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphopenia | 1 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea/Vomiting | 1 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 3 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other gastrointestinal | 3 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphopenia | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genito urinary | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 1 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alopecia | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 7 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Transfusions | 1 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 5 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 2 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 1 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 1 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 0 participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 3 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 2 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Transfusions | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 2 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other gastrointestinal | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genito urinary | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea/Vomiting | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 2 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 1 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphopenia | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alopecia | 0 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 1 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 1 participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 1 participants |
Primary
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.
Population: Eligible and treated patients with sufficient follow-up assessments to evaluate response
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topotecan Hydrochloride | Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | Partial response | 0 participants |
| Topotecan Hydrochloride | Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | Complete response | 0 participants |