A Phase I Study of Intraperitoneal Hyperthermic Docetaxel

NCT00474669 | Completed Phase 1 DMC

• 1 other identifier: BCC-GYN-07-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the maximum tolerated dose of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma.

Conditions

Ovarian Carcinoma

Keywords

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Assess the MTD of docetaxel administered intraperitoneally with heat at the time of second-look surgery in patients with stage II/III ovarian carcinoma following surgery and normothermic intraperitoneal and intravenous cisplatin and paclitaxel.

  6 months-5 years

Secondary Outcomes (1)

• To assess the quality of life of patients treated with intraperitoneal hyperthermic chemotherapy in this setting

  6 months-5 years

Study Arms (1)

Docetaxel

EXPERIMENTAL

Intraperitoneal Docetaxel administered with heat

Drug: docetaxel

Interventions

docetaxel DRUG

Docetaxel will be administered in normal-saline delivered at an inflow temperature of 42 degreesC for 90 minutes by the technique described in Appendix D of the protocol

Docetaxel

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have had a complete clinical response (negative clinical examination, CA125 and CT scan of chest, abdomen and pelvis) to front-line therapy for stage II/III ovarian, primary peritoneal or Fallopian tube carcinoma. This will have included initial surgery followed by combined IV/IP chemotherapy with cisplatin and paclitaxel. Patients must have had a minimum of three courses of IP therapy with both paclitaxel and cisplatin
• Second surgery to be performed no more than 3 months from last course of initial chemotherapy
• Age greater than 18 years and negative pregnancy if has child-bearing potential
• GOG performance status less than 2
• Medically fit for surgery
• Patients must have normal organ and marrow function as defined in the protocol hepatic function Total Bilirubin ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values AST or ALT) should be used.
• Ability to understand and the willingness to sign a written informed consent document.
• The effects of docetaxel on the developing human fetus are unknown. For this reason and because taxanes are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

You may not qualify if:

• Patients who have completed front-line therapy for ovarian cancer more than 3 months prior to HIPEC.
• Patients receiving any other investigational agents.
• Patients with stage IV disease including previous parenchymal liver disease, brain metastasis or cytologically-confirmed chest metastasis
• Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition used in this study in addition to Taxotere.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• More than grade 2 peripheral neuropathy from prior chemotherapy
• Pregnant, breast-feeding or known to be HIV positive
• Prior malignancy other than non-melanomatous skin cancer more than 5 years ago
• No prior chemotherapy other than for front-line ovarian cancer or radiation for any reason.
• Stomatitis of any grade
• Uncontrolled intercurrent illness or other conditions that would limit compliance with study requirements should be excluded.

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• 1 - R. Bruno, D. Hille, L. Thomas, A. Riva and L.B. Sheiner. Population Pharmacokinetics / Pharmacodynamics (PK/PD) of Docetaxel (Taxotere) in Phase II studies. Proc. ASCO, 14, 457, 1995. 2 - S. L. Beal, A.J. Boeckman and L.B. Sheiner. NONMEM version 4. User's Guide Part I to VI. University of California at San Francisco, San Francisco, 1988 - 1992.

  RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Docetaxel

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 Officials

• C. William Helm, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 17, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (1)