TriangleNCT00006227 · REGISTRY CONDITION SEARCH
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2020-03-05
This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor \[androblastoma\], steroid \[lipid\] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules) * Patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen * Patients must have measurable disease as defined by Gynecological Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria * White blood count equal to or greater than 3000/mcl * Granulocyte count equal to or greater than 1500/mcl * Platelet count equal to or greater than 100,000/mcl * Creatinine equal to or less than 2.0 mg% * Bilirubin less than or equal to 1.5 times normal * Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal * Patients with a GOG performance grade of 0, 1 or 2 * Patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control * Patients who have met the pre-entry requirements as specified * Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization Exclusion Criteria: * Patients with GOG performance grade of 3 or 4 * Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy * Patients having received more than one prior chemotherapy regimen * Patients amenable to cure by surgery * Patients with prior radiation except for those whose recurrent disease is outside the radiation port
- healthy Volunteers
- false
- sex
- FEMALE
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
- intervention Names
- Drug: Paclitaxel
- label
- Treatment (paclitaxel)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Treatment (paclitaxel)
- description
- Given IV
- name
- Paclitaxel
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 31
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma
- measure
- Probability of Complete Clinical Response
- time Frame
- Up to 5 years
- secondary Outcomes
- description
- Duration of progression free survival (median) (months)
- measure
- Progression-free Survival
- time Frame
- The period from study entry until disease progression, death or date of last contact
- description
- Duration of overall survival (median) (months)
- measure
- Overall Survival
- time Frame
- The observed length of life from entry into the study to death or the date of last contact
Full study description
- brief Summary
- This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
- detailed Description
- PRIMARY OBJECTIVES: I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma. II. To evaluate the value of inhibin for predicting response. OUTLINE: Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-1a81db6c897b4ca82d92
- requested nct id
- NCT00006227
- primary nct id
- NCT00006227
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
- payload sha256
- f768369f0072cde52021928b19425cdaea66388ac8f6b28f65e04ca3112642ab
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-1a81db6c897b4ca82d92
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT00006227
- occurrences
- context exact
- NCT00006227
- end
- 11
- exact text
- NCT00006227
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Testicular Cancer
- query disease state id
- ds-testicular-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
- source file sha256
- 9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
- source json pointer
- /studies/33/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 947d57224a1261b41dcb14581ab3abd22c2b4a2001531206c35986f71b4b8654
Preserved source evidence · Not medical advice