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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00066456

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

1.9

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Recurrent Ovarian Carcinoma Stage III Ovarian Cancer Stage IV Ovarian Cancer	Radiation: 3-Dimensional Conformal Radiation Therapy Drug: Chemosensitization/Potentiation Therapy Drug: Docetaxel	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Radiation: 3-Dimensional Conformal Radiation Therapy Other Names: 3-dimensional radiation therapy 3D CONFORMAL RADIATION THERAPY 3D CRT 3D-CRT Conformal Therapy Radiation Conformal Therapy Drug: Chemosensitization/Potentiation Therapy Drug: Docetaxel Given IV Other Names: Docecad RP56976 Taxotere Taxotere Injection Concentrate

Arm

Intervention/Treatment

Experimental: Treatment (chemosensitization, radiation, docetaxel)

Radiation: 3-Dimensional Conformal Radiation Therapy

Other Names:

3-dimensional radiation therapy

3D CONFORMAL RADIATION THERAPY

3D CRT

3D-CRT

Conformal Therapy

Radiation Conformal Therapy

Drug: Chemosensitization/Potentiation Therapy

Drug: Docetaxel

Given IV

Other Names:

Docecad

RP56976

Taxotere

Taxotere Injection Concentrate

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
2	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
3	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242
4	University of Kentucky/Markey Cancer Center	Lexington	Kentucky	United States	40536
5	Case Western Reserve University	Cleveland	Ohio	United States	44106
6	Lake University Ireland Cancer Center	Mentor	Ohio	United States	44060
7	Cancer Care Associates-Midtown	Tulsa	Oklahoma	United States	74104