Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
Completed · Phase 1
Conditions studied: Fallopian Tube Carcinoma, Malignant Ovarian Mixed Epithelial Tumor, Ovarian Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Undifferentiated Ovarian Carcinoma
In brief
This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer. Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with carboplatin may kill more tumor cells.
Key facts
- Study ID
- NCT00060359
- Run by
- Gynecologic Oncology Group
- People needed
- 32
- Starts
- 2003-04-01
- Last updated by the study team
- 2015-05-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma
- Stage III or IV
- Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
- The following histologic epithelial cell types are eligible:
- Serous adenocarcinoma
- Mucinous adenocarcinoma
- Clear cell adenocarcinoma
- Transitional cell carcinoma
- Adenocarcinoma not otherwise specified
- Endometrioid adenocarcinoma
- Undifferentiated carcinoma
- Mixed epithelial carcinoma
- Malignant Brenner tumor
- No epithelial tumors of low malignant potential (borderline tumors)
- Surgery performed within the past 12 weeks
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- No active bleeding
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastasis)
- Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastasis)
- No acute hepatitis
- PT and PTT normal
- Creatinine no greater than 1.5 times ULN
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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