A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients

NCT00001272 | Completed Phase 1

• 2 other identifiers: 91023291-C-0232
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.

Conditions

Ovarian Neoplasms

Keywords

Adult; Cytotoxic Chemotherapy; Hematopoietic Growth Factor

Interventions

taxol DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

All patients must have biopsy proven ovarian cancer as determined by evaluation in the Laboratory of Pathology, NCI. Germ cell and borderline histologies are specifically excluded. Patients must have FIGO stage III and IV disease, or FIGO Stage IIC disease with poorly differentiated histology, and will undergo attempted surgical debulking prior to the initiation of chemotherapy. Prior chemotherapy or radiation therapy will make a patient ineligible. Performance status: less than or equal to ECOG 2. Patients must have the following end organ function: No brain involvement. No history of myocardial infarction, cardiac arrhythmias requiring therapy, right bundle branch block with left anterior hemiblock, and left bundle branch block. Renal function: creatinine clearance greater than or equal to 60 cc/min; patients with ureteral obstruction must have this corrected prior to starting therapy. Hepatic function: normal coagulation parameters, serum transaminases within 3 times upper limit of normal. Neurologic function: no preexisting dysfunction greater than grade 1 (exclusive of mild vibratory delay). No recent history of active GI bleeding. Hematologic parameters prior to starting cycle 1 of therapy: total granulocyte count greater than 2000 and platelet count greater than 100,000. Patients may not have had prior history of invasive malignancy with the exception of nonmelanoma skin cancer curatively treated. Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol. Patients must be able to begin therapy within 8 weeks of staging laparotomy and should have a central venous catheter placed for infusion of chemotherapy. All patients must be registered by calling the Orkand Corporation at 402-1732 between the hours of 8:30 AM and 5:00 PM; eligibility criteria will be queried.

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: September 1, 1991
• Study Completion: May 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-06

Locations

US (1)