Cisplatin Induction With Paclitaxel Consolidation for Stage III-IV Epithelial Ovarian and Primary Peritoneal Cancer

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Clinically, there has been extensive experience with topotecan and cisplatin. Recently, several investigators have evaluated the combination of paclitaxel, cisplatin and topotecan. As expected, myelosuppression was the dose-limiting factor. Herben et al recently reported the results of a phase I trial using the combination of paclitaxel, cisplatin, and topotecan as first line therapy in advanced stage ovarian cancer. Interestingly, the authors could not achieve a dose of topotecan that would be considered "optimal" for the treatment of relapsed disease in a single-agent fashion. The inability to utilize a therapeutic dose when combined with either platinum or paclitaxel has been demonstrated in previous reports and affirms the bone marrow suppressive effect. The clinical response rate from this trial was reported as 86.7%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John P. Fruehauf
• Collaborator: GlaxoSmithKline
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel; Topotecan

Criteria

Eligible Subjects:

1. Subjects with a histologic diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma, stage III or IV, as outlined above. All subjects must have appropriate surgery for ovarian carcinoma with appropriate tissue for histologic evaluation and evaluated by the EDR assay.

2. Eligible cell types include:

Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor

3. Adequate bone marrow, renal, and hepatic function as defined by WBC3000cells/mcl, platelets 100,000/mcl, serum creatinine 2mg/dcl, bilirubin 1.5times normal, and SGOT 3 times normal.

4. Subjects with GOG Performance Status of 0, 1, or 2.

5. Subjects must have a complete history and physical examination done by the investigators of this study. Also, CBC with differential, electrolytes, serum creatinine, liver function tests and CA 125 must be done 14 days prior to registration.

6. Subjects must be informed of the investigational nature of this study and must provide informed consent in accordance with institutional and federal guidelines.

7. All subjects must have histologic slides available for pathology review.

8. Subjects must be entered within six weeks of surgery.

Ineligible Subjects:

1. Subjects with epithelial ovarian carcinoma of low malignant potential.

2. Subjects who have received prior radiotherapy or chemotherapy.

3. Subjects with septicemia, severe infection, or acute hepatitis.

4. Subjects with severe gastrointestinal bleeding.

5. Subjects with a GOG Performance Status of 3 or 4.

6. Subjects with other invasive malignancies, with the exception of non-melanoma skin cancer, who had or have any evidence of other cancer within the last 5 years or whose previous cancer treatment contradicts this protocol therapy.

7. Subjects who are pregnant will be excluded.