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

Brief Title

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

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

Brief Summary

      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. 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.

Detailed Description

      OBJECTIVES:

      I. 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.

      II. 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Incidence of acute toxicity, graded using Common Toxicity Criteria version 2.0

Secondary Outcome

 Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria version 2.0 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (CTC v2.0 RTOG/EORTC) late radiation morbidity scoring

Condition

Fallopian Tube Carcinoma

Intervention

3-Dimensional Conformal Radiation Therapy

Study Arms / Comparison Groups

 Treatment (chemosensitization, radiation, docetaxel)

Description:  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.

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

Radiation

Estimated Enrollment

Start Date

September 2003

Primary Completion Date

July 2010

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  Performance status - GOG 0-1

          -  WBC at least 3,000/mm^3

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  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

          -  Creatinine no greater than 1.5 times ULN

          -  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

          -  No prior radiotherapy to the abdomen or pelvis

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Paula Fracasso, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00066456

Organization ID

GOG-9915

Secondary IDs

NCI-2009-00618

Responsible Party

Sponsor

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Paula Fracasso, Principal Investigator, Gynecologic Oncology Group

Verification Date

February 2016