A Phase 3 interventional study of carboplatin and paclitaxel in Ovarian Cancer, sponsored by Gynecologic Oncology Group. Completed at 151 sites in 2 countries. Open to female participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2019-06-04.
Sponsored by Gynecologic Oncology Group · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 571 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later
Drug: carboplatin · Drug: paclitaxel
carboplatin, paclitaxel
Drug: carboplatin · Drug: paclitaxel
Progression-free Survival
The percent of participants with disease recurrence within 5 years
Time frame: Up to 5 years
Overall Survival
Number of deaths during study and follow up.
Time frame: up to 96 months
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
GOG 0175 accrued 571 patients from September 1998 to December 2006.
| Milestone | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Paclitaxel + Carboplatin Followed by Observation |
|---|---|---|
| Started | 289 | 282 |
| Completed | 274 | 268 |
| Not completed | 15 | 14 |
The percent of participants with disease recurrence within 5 years
| percentage of participants | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Paclitaxel + Carboplatin Followed by Observation |
|---|---|---|
| Progression-free Survival | 20.4 (15.9 to 25.9) | 23.2 (18.4 to 28.9) |
Number of deaths during study and follow up.
| Participants | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Paclitaxel + Carboplatin Followed by Observation |
|---|---|---|
| Overall Survival | 44 | 53 |
Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants
| Participants | Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 24 Cycles | Grade 3 & Above Toxicity Paclitaxel + Carboplatin x 3 Cycles |
|---|---|---|
| Leukopenia | 74 | 86 |
| Thrombocytopenia | 12 | 16 |
| Neutropenia | 203 | 196 |
| Anemia | 4 | 2 |
| Other hematologic | 7 | 4 |
| Allergy | 8 | 7 |
| Cardiovascular | 12 | 7 |
| Coagulation | 0 | 2 |
| Constitutional | 7 | 7 |
| Dermatologic | 2 | 3 |
| Gastrointestinal | 12 | 11 |
| Genitourinary/Renal | 1 | 3 |
| Hemorrhage | 1 | 0 |
| Hepatic | 1 | 1 |
| Infection/Fever | 15 | 11 |
| Metabolic | 10 | 5 |
| Musculoskeletal | 3 | 0 |
| Peripheral Neuropathy | 12 | 2 |
| Other Neurologic | 5 | 8 |
| Ocular/Visual | 1 | 0 |
| Pain | 15 | 12 |
| Pulmonary | 1 | 0 |
Collected over Up to 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | 44/274 (16.1%) | 7/274 (2.6%) | 271/274 (98.9%) |
| Paclitaxel + Carboplatin Followed by Observation | 53/268 (19.8%) | 5/268 (1.9%) | 265/268 (98.9%) |
| Event | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Paclitaxel + Carboplatin Followed by Observation |
|---|---|---|
| Abdominal PainGeneral disorders | 2/274 | 0/268 |
| Chest PainGeneral disorders | 0/274 | 1/268 |
| NauseaGastrointestinal disorders | 1/274 | 1/268 |
| VomitingGastrointestinal disorders | 1/274 | 1/268 |
| Cardiac ArrythmiaCardiac disorders | 0/274 | 1/268 |
| Fever with NeutropeniaInvestigations | 0/274 | 1/268 |
| Death due to DiseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/274 | 1/268 |
| Urinary Tract Infection With E.Coli BacteremiaInfections and infestations | 1/274 | 0/268 |
| Irritable bowel syndromeGastrointestinal disorders | 1/274 | 0/268 |
| Venous ThrombosisVascular disorders | 1/274 | 0/268 |
| Event | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Paclitaxel + Carboplatin Followed by Observation |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 255/274 | 247/268 |
| LeukopeniaBlood and lymphatic system disorders | 247/274 | 236/268 |
| AnemaBlood and lymphatic system disorders | 219/274 | 209/268 |
| DermatologicSkin and subcutaneous tissue disorders | 215/274 | 183/268 |
| GastrointestinalGastrointestinal disorders | 193/274 | 180/268 |
| ConstitutionalGeneral disorders | 182/274 | 159/268 |
| PainGeneral disorders | 164/274 | 150/268 |
| Peripheral neurologicNervous system disorders | 156/274 | 108/268 |
| ThrombocytopeniaBlood and lymphatic system disorders | 122/274 | 109/268 |
| NeurologicNervous system disorders | 73/274 | 50/268 |
| Age, Customized(Participants) | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Paclitaxel + Carboplatin Followed by Observation | Total |
|---|---|---|---|
| Less than 40 years | 22 | 21 | 43 |
| 40-49 years | 66 | 56 | 122 |
| 50-59 years | 88 | 98 | 186 |
| 60-69 years | 64 | 57 | 121 |
| >=70 years | 34 | 36 | 70 |
| Sex: Female, Male(Participants) | Paclitaxel + Carboplatin Followed 4 Weeks Later by Paclitaxel | Paclitaxel + Carboplatin Followed by Observation | Total |
|---|---|---|---|
| Female | 274 | 268 | 542 |
| Male | 0 | 0 | 0 |
Showing the first 100 of 151 sites across 2 countries.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Gynecologic Oncology Group