Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca

NCT00787488 | Withdrawn

• 1 other identifier: Pro00008510
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.

Conditions

Ovarian Cancer

Keywords

Ovarian; debulked; recurrent; Stage III; Stage IV

Outcome Measures

Primary Outcomes (1)

• Toxicity

  6 months

Secondary Outcomes (1)

• Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging

  1 year

Study Arms (1)

1

EXPERIMENTAL

Chemotherapy plus Hyperthermia

Device: Hyperthermia

Interventions

Hyperthermia DEVICE

Every 3 weeks

1

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
• Optimal debulking (\< 1cm residual disease) of their disease within 6 weeks of the start of the study
• Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy
• GOG performance status 0, 1, or 2
• Patients must have normal organ and marrow function defined as:
• absolute neutrophil count \>1,500/mcL
• platelets \>100,000/mcL
• total bilirubin and creatinine \<1.5 X institutional upper limit of normal(ULN)
• AST(SGOT)/ALT(SGPT)\<3 X institutional ULN

You may not qualify if:

• Patients with biochemical recurrences or evidence of measurable disease
• Patients with suboptimal (\>1 cm) residual disease
• Patients who have had chemotherapy within 4 weeks prior
• Receiving any investigational agents
• Known brain metastases
• Epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
• Uncontrolled intercurrent illness
• Prior radiation therapy
• History of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years

Sponsors & Collaborators

• Mark Dewhirst: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

Diathermy

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Elizabeth Jewell, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Angeles Secord, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Ellen Jones, MD, PhD

  Duke University Medical Center, Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: April 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 11, 2014

Record last verified: 2014-11