Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

August 6, 2003

Last Updated Date

February 17, 2009

Start Date ^ICMJE

October 2003

Estimated Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dose-limiting toxicity at 1 year [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Dose-limiting toxicity at 1 year

Change History

Complete list of historical versions of study NCT00066456 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer

Official Title ^ICMJE

A Phase I Study Using Low Dose Abdominal Radiotherapy As A Docetaxel Chemosensitizer For Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of low-dose radiation therapy to the abdomen combined with docetaxel in treating patients who have recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer.

Detailed Description

OBJECTIVES:

Determine the maximum tolerated dose of docetaxel in combination with low-dose abdominal radiotherapy in patients with recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer.
Determine the safety and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of docetaxel.

Patients receive docetaxel IV over 30 minutes once daily on days 1, 8, 15, 22, 29, and 35. Within 3 hours after beginning docetaxel, patients also receive low-dose abdominal radiotherapy twice daily (at least 4 hours apart) on days 1, 2, 8, 9, 15, 16, 22, 24, 29, 30, 35, and 36. Treatment continues in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 0.25-2.5 years.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer

Intervention ^ICMJE

Drug: chemosensitization/potentiation therapy
Drug: docetaxel
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of ovarian, peritoneal, or fallopian tube carcinoma
Radiographic, clinical, or pathologic evidence of relapse
Recurrent or persistent disease after chemotherapy (may be enrolled at first or subsequent relapse)
- Received prior taxane OR platinum agent

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

GOG 0-1

Life expectancy

Not specified

Hematopoietic

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT/SGPT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN

Renal

Creatinine no greater than 1.5 times ULN

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No grade 2 or greater neuropathy (sensory or motor)
No septicemia
No severe infection
No circumstance that would preclude study completion

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to the abdomen or pelvis

Surgery

Patients with ureteral obstruction must undergo stent or nephrostomy tube replacement prior to study entry

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00066456

Responsible Party

Study ID Numbers ^ICMJE

CDR0000316238, GOG-9915

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	Paula M. Fracasso, MD, PhD	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Investigator:	Katherine Y. Look, MD	Indiana University Melvin and Bren Simon Cancer Center
Investigator:	Richard Kryscio, PhD	Lucille P. Markey Cancer Center at University of Kentucky

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP