Ovarian Cancer
Conditions
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, Brenner tumor
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.
Detailed description
OBJECTIVES: * Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel. * Assess the frequency and severity of toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks. * Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.
Interventions
DRUGcarboplatin
DRUGpaclitaxel
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types: * Serous adenocarcinoma * Malignant Brenner's tumor * Mucinous adenocarcinoma * Endometrioid * Adenocarcinoma * Clear cell adenocarcinoma * Undifferentiated carcinoma * Transitional cell * Mixed epithelial carcinoma * Adenocarcinoma - not otherwise specified * Meets 1 of the following criteria: * Stage Ia or Ib, grade 3 or clear cell * Stage Ic or II, all grades/histologies * Complete surgical staging * No tumors of low malignant potential (borderline tumors) PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-3 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times normal * Alkaline phosphatase no greater than 3 times normal * SGOT no greater than 3 times normal Renal: * Creatinine no greater than 2.0 mg/dL Other: * No other invasive malignancies within the past 5 years except nonmelanoma skin cancer * No major systemic medical illness expected to affect survival * Body surface area no greater than 2.0 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No prior treatment for this malignancy except surgical staging * No prior anticancer therapy that would preclude study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Up to 5 years | The percent of participants with disease recurrence within 5 years |
| Overall Survival | up to 96 months | Number of deaths during study and follow up. |
| Number of Participants With Adverse Events Grade 3 or Greater | Throughout study treatment lasting up to 24 weeks | Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants |
Countries
Japan, United States
Participant flow
Recruitment details
GOG 0175 accrued 571 patients from September 1998 to December 2006.
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles Followed 4 weeks later by paclitaxel 40 mg/m2 over 1 hour every week for 24 weeks | 274 |
| Paclitaxel + Carboplatin Followed by Observation Paclitaxel 175 mg/m2 IV over 3 hours, Carboplatin AUC=6 IV every 21 days x 3 cycles, followed by observation | 268 |
| Total | 542 |
Baseline characteristics
| Characteristic | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Paclitaxel + Carboplatin Followed by Observation | Total |
|---|---|---|---|
| Age, Customized 40-49 years | 66 Participants | 56 Participants | 122 Participants |
| Age, Customized 50-59 years | 88 Participants | 98 Participants | 186 Participants |
| Age, Customized 60-69 years | 64 Participants | 57 Participants | 121 Participants |
| Age, Customized >=70 years | 34 Participants | 36 Participants | 70 Participants |
| Age, Customized Less than 40 years | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Female | 274 Participants | 268 Participants | 542 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 | 44 / 274 | 53 / 268 |
| other Total, other adverse events | 271 / 274 | 265 / 268 |
| serious Total, serious adverse events | 7 / 274 | 5 / 268 |
Outcome results
Primary
Number of Participants With Adverse Events Grade 3 or Greater
Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants
Time frame: Throughout study treatment lasting up to 24 weeks
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Musculoskeletal | 3 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Leukopenia | 74 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Thrombocytopenia | 12 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Neutropenia | 203 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Anemia | 4 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Other hematologic | 7 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Allergy | 8 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Cardiovascular | 12 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Coagulation | 0 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Constitutional | 7 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Dermatologic | 2 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Gastrointestinal | 12 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Genitourinary/Renal | 1 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Hemorrhage | 1 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Hepatic | 1 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Infection/Fever | 15 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Metabolic | 10 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Peripheral Neuropathy | 12 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Other Neurologic | 5 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Ocular/Visual | 1 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Pain | 15 Participants |
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Number of Participants With Adverse Events Grade 3 or Greater | Pulmonary | 1 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Gastrointestinal | 11 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Musculoskeletal | 0 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Leukopenia | 86 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Genitourinary/Renal | 3 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Thrombocytopenia | 16 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Pain | 12 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Neutropenia | 196 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Hemorrhage | 0 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Anemia | 2 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Peripheral Neuropathy | 2 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Other hematologic | 4 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Hepatic | 1 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Allergy | 7 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Ocular/Visual | 0 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Cardiovascular | 7 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Infection/Fever | 11 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Coagulation | 2 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Other Neurologic | 8 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Constitutional | 7 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Metabolic | 5 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Dermatologic | 3 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Number of Participants With Adverse Events Grade 3 or Greater | Pulmonary | 0 Participants |
Primary
Overall Survival
Number of deaths during study and follow up.
Time frame: up to 96 months
Population: All eligible and treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Overall Survival | 44 Participants |
| Paclitaxel + Carboplatin Followed by Observation | Overall Survival | 53 Participants |
Primary
Progression-free Survival
The percent of participants with disease recurrence within 5 years
Time frame: Up to 5 years
Population: Eligible and treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Progression-free Survival | 20.4 percentage of participants |
| Paclitaxel + Carboplatin Followed by Observation | Progression-free Survival | 23.2 percentage of participants |