Adult Type Ovarian Granulosa Cell Tumor, Ovarian Gynandroblastoma, Ovarian Sertoli-Leydig Cell Tumor, Ovarian Sex Cord Tumor With Annular Tubules, Ovarian Steroid Cell Tumor
Conditions
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.
Interventions
DRUGPaclitaxel
Given IV
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
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of Complete Clinical Response | Up to 5 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | The period from study entry until disease progression, death or date of last contact | Duration of progression free survival (median) (months) |
| Overall Survival | The observed length of life from entry into the study to death or the date of last contact | Duration of overall survival (median) (months) |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Paclitaxel) Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Treatment (Paclitaxel) |
|---|---|
| Age, Customized < 40 | 7 participants |
| Age, Customized 40-49 | 8 participants |
| Age, Customized 50-59 | 9 participants |
| Age, Customized >= 60 | 7 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 7 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 | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 31 |
| other Total, other adverse events | 31 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
Primary
Probability of Complete Clinical Response
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
Time frame: Up to 5 years
Population: Eligible and evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Paclitaxel) | Probability of Complete Clinical Response | 3.2 Percentage of Participants |
Secondary
Overall Survival
Duration of overall survival (median) (months)
Time frame: The observed length of life from entry into the study to death or the date of last contact
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Paclitaxel) | Overall Survival | 73.6 Months |
Secondary
Progression-free Survival
Duration of progression free survival (median) (months)
Time frame: The period from study entry until disease progression, death or date of last contact
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Paclitaxel) | Progression-free Survival | 10.0 Months |