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

Phase 1

Completed

• Conditions: Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma; Stage III Ovarian Cancer; Stage IV Ovarian Cancer
• Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy; Drug: Chemosensitization/Potentiation Therapy; Drug: Docetaxel

• Registration Number: NCT00066456
• Lead Sponsor: Gynecologic Oncology Group

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 Timeline

• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Study Start: 2003-09
• Primary Completion: 2010-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (chemosensitization, radiation, docetaxel)	3-Dimensional Conformal Radiation Therapy	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.
Treatment (chemosensitization, radiation, docetaxel)	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.
Treatment (chemosensitization, radiation, docetaxel)	Chemosensitization/Potentiation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Incidence of acute toxicity, graded using Common Toxicity Criteria version 2.0	Up to 30 days after completion of radiation therapy

Secondary Outcome Measures

Name	Time	Method
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	Up to 5 years

Trial Locations

Locations (7)

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

University of Iowa/Holden Comprehensive Cancer Center; 🇺🇸 Iowa City, Iowa, United States

Lake University Ireland Cancer Center; 🇺🇸 Mentor, Ohio, United States

Cancer Care Associates-Midtown; 🇺🇸 Tulsa, Oklahoma, United States

University of Kentucky/Markey Cancer Center; 🇺🇸 Lexington, Kentucky, United States