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

NCT00314678 | Completed Phase 2

• 1 other identifier: UCI 99-25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Epithelial Ovarian Cancer; Primary Peritoneal Cancer

Keywords

Ovarian; Peritoneal

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Interval

Secondary Outcomes (1)

• Examine the toxicity of therapy and to develop suitable strategies for dose modification.

Interventions

Topotecan DRUG

Cisplatin DRUG

Paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• John P. Fruehauf: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Topotecan; Cisplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• John P Fruehauf, MD, PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. John P. Fruehauf

Study Record Dates

• First Submitted: April 12, 2006
• First Posted: April 14, 2006
• Study Start: September 1, 2005
• Study Completion: April 1, 2007
• Last Updated: December 8, 2016

Record last verified: 2007-12

Locations

US (1)