Written informed consent
Item
1. Written informed consent
boolean
C0021430 (UMLS CUI [1])
Females at least 18 years of age.
Item
2. Females at least 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Histologic; Diagnosis | Epithelial ovarian cancer | Fallopian Tube Carcinoma | Primary peritoneal carcinoma | Mixed Tumor, Mullerian
Item
3. Histologically diagnosed disease consistent with epithelial ovarian carcinoma that is now recurrent (Inclusion Criterion #6). In addition, fallopian tube, primary peritoneal, and mixed mullerian tumors will also be aIlowed.
boolean
C0205462 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0677886 (UMLS CUI [2])
C0238122 (UMLS CUI [3])
C1514428 (UMLS CUI [4])
C0206627 (UMLS CUI [5])
Prior Chemotherapy | Chemotherapy Regimen; Platinum-Based | Carboplatin | Cisplatin | primary disorders
Item
4. Patients who had one prior platinum—based chemotherapeutic regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for the treatment of primary disease.
boolean
C1514457 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0079083 (UMLS CUI [3])
C0008838 (UMLS CUI [4])
C0277554 (UMLS CUI [5])
Lesion; Measurable; 2-Dimensional | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
5. Presence of at least one bidimensionally measurable lesion as determined by diagnostic studies including CT or MRI.
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
Platinum; Sensitive | Gynecologic Oncology Group | Interval; Disease; Free of (attribute) | Response to treatment; Platinum
Item
6. Patients must be considered platinum-sensitive according to standard GOG criteria (i.e.,have had a treatment-free interval following response to platinum of greater than 6 months).
boolean
C0032207 (UMLS CUI [1,1])
C0332324 (UMLS CUI [1,2])
C1512288 (UMLS CUI [2])
C1272706 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0521982 (UMLS CUI [4,1])
C0032207 (UMLS CUI [4,2])
Operative Surgical Procedures | Therapeutic radiology procedure | Measurable Disease; Location
Item
7. At least 4 weeks since last surgery or radiation therapy. The measurable Iesions may not be in the field of prior radiation.
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1513041 (UMLS CUI [3,1])
C0450429 (UMLS CUI [3,2])
ECOG performance status
Item
8. ECOG performance status of 0, 1, or 2 and life expectancy >= 3 months.
boolean
C1520224 (UMLS CUI [1])
Laboratory values
Item
9. Laboratory values
boolean
C0022885 (UMLS CUI [1])
Female of child bearing age; Contraceptive methods | Contraceptives, Oral | Vaginal contraceptive diaphragm (device); Spermatocidal Agents | Intrauterine Device Dosage Form
Item
1. Women of child-bearing potential who are not practicing adequate contraception (e.g., oral contraceptives, diaphragm plus spermicide, or IUD) for at least three months before the start of the study.
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0042241 (UMLS CUI [3,1])
C0037862 (UMLS CUI [3,2])
C1706306 (UMLS CUI [4])
Pregnancy; Breast Feeding
Item
2. Patients who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Histopathologic Grade | Borderline; Carcinoma; epithelial | Low Grade Malignant Neoplasm; Carcinoma; epithelial
Item
3. Histologic diagnosis of borderline, low-malignant potential grade (Grade 0) epithelial carcinoma.
boolean
C0919553 (UMLS CUI [1])
C0205189 (UMLS CUI [2,1])
C0007097 (UMLS CUI [2,2])
C0221908 (UMLS CUI [2,3])
C1334425 (UMLS CUI [3,1])
C0007097 (UMLS CUI [3,2])
C0221908 (UMLS CUI [3,3])
Prior Chemotherapy; Chemotherapy Regimen; Numbers
Item
4. Patients who received more than one prior chemotherapy regimen.
boolean
C1514457 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Comorbidity; Malignant Neoplasms | Basal cell carcinoma; Treating; Adequate | Squamous cell carcinoma of skin; Treating; Adequate | Carcinoma in situ of uterine cervix | Incidental Findings; Carcinoid Tumor | Disease; Free of (attribute)
Item
5. Other concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease—free for 5 years.
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4])
C0743997 (UMLS CUI [5,1])
C0007095 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
Communicable Diseases; Requirement; Antibiotic therapy
Item
6. Active uncontrolled infection requiring treatment with antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0338237 (UMLS CUI [1,3])
Comorbidity; Severe (severity modifier); Malignant Neoplasms; Unrelated (finding) | Compliance behavior | Risk; Extreme | Life Expectancy
Item
7. Concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0445356 (UMLS CUI [1,4])
C1321605 (UMLS CUI [2])
C0035647 (UMLS CUI [3,1])
C0205403 (UMLS CUI [3,2])
C0023671 (UMLS CUI [4])
Therapeutic radiology procedure | Bone Marrow
Item
8. Patients who have received radiation to more than 10% of marrow-bearing areas.
boolean
C1522449 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
Concomitant Agent; Chemotherapeutic agent | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Operative Surgical Procedures | cancer treatment
Item
9. Patients for whom other concomitant chemotherapeutic agents, immunotherapy, hormonal therapy, radiation therapy, surgery, or anticancer treatment is planned.
boolean
C2347852 (UMLS CUI [1,1])
C0729502 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0920425 (UMLS CUI [6])
Prior Therapy | Topotecan | gemcitabine
Item
10. Prior treatment with topotecan or gemcitabine.
boolean
C1514463 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
C0045093 (UMLS CUI [3])
Camptothecin; Hypersensitivity | Nucleoside Analogs; Hypersensitivity | Compound (substance); Relationships
Item
11. Hypersensitivity to camptothecin or nucleoside analogues, or chemically related compounds.
boolean
C0006812 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1579410 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1706082 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
INVESTIGATIONAL AGENTS; Before; Clinical Trial Period
Item
12. Use of an investigational agent within 30 days or 5 half-lives (whichever is longer) preceding entry into this study.
boolean
C1875319 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Did the patient meet all inclusion and exclusion criteria?
Item
Did the patient meet all inclusion and exclusion criteria?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])