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

NCT ID: NCT00066456

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30

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.

Conditions

Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma; Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (chemosensitization, radiation, 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.

Group Type: EXPERIMENTAL

3-Dimensional Conformal Radiation Therapy

Intervention Type: RADIATION

Chemosensitization/Potentiation Therapy

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Given IV

Interventions

3-Dimensional Conformal Radiation Therapy

Intervention Type: RADIATION

Chemosensitization/Potentiation Therapy

Intervention Type: DRUG

Docetaxel

Given IV

Intervention Type: DRUG

Other Intervention Names

3-dimensional radiation therapy; 3D CONFORMAL RADIATION THERAPY; 3D CRT; 3D-CRT; Conformal Therapy; Radiation Conformal Therapy; Docecad; RP56976; Taxotere; Taxotere Injection Concentrate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paula Fracasso

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Case Western Reserve University

Cleveland, Ohio, United States

Lake University Ireland Cancer Center

Mentor, Ohio, United States

Cancer Care Associates-Midtown

Tulsa, Oklahoma, United States

Countries

United States

Other Identifiers

NCI-2009-00618

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000316238

Identifier Type: -

Identifier Source: secondary_id

GOG-9915

Identifier Type: -

Identifier Source: secondary_id

GOG-9915

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-9915

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-9915

Identifier Type: -

Identifier Source: org_study_id