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

G

Gynecologic Oncology Group (GOG)

Status and phase

Completed
Phase 1

Conditions

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

Treatments

Drug: Chemosensitization/Potentiation Therapy
Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Docetaxel

Study type

Interventional

Funder types

NETWORK
NIH

Identifiers

NCT00066456
U10CA027469 (U.S. NIH Grant/Contract)
GOG-9915
CDR0000316238
NCI-2009-00618 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Treatment (chemosensitization, radiation, docetaxel)
Experimental group
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.
Treatment:
Drug: Docetaxel
Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Chemosensitization/Potentiation Therapy

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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