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


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity at 1 year

Safety Issue:

Yes

Principal Investigator

Paula M. Fracasso, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000316238

NCT ID:

NCT00066456

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • fallopian tube cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929