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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00066456
First received: August 6, 2003
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: chemosensitization/potentiation therapy
Drug: docetaxel
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study Using Low Dose Abdominal Radiotherapy As A Docetaxel Chemosensitizer For Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Dose-limiting toxicity at 1 year [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2003
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066456

Locations
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates - Saint Francis Campus
Tulsa, Oklahoma, United States, 74136-1929
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Paula M. Fracasso, MD, PhD Washington University Siteman Cancer Center
Study Chair: Katherine Y. Look, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00066456     History of Changes
Other Study ID Numbers: gGOG-9915, CDR0000316238, NCI-2009-00618
Study First Received: August 6, 2003
Last Updated: August 19, 2013
Health Authority: United States: Federal Government
United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer
fallopian tube cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014