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Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003120
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter period of time is as effective as a standard course of treatment for advanced ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3 months with that of paclitaxel given for 12 months in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: paclitaxel
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 450
Study Start Date: November 1997
Detailed Description:

OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on progression free survival and overall survival in women with advanced ovarian, fallopian tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated with prolonged paclitaxel administration in these patients.

OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression or 1 year from registration, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 5 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer Must have undergone an initial exploratory laparotomy with tumor debulking AND Must be FIGO stage IIIA, IIIB, IIIC, or IV at the time of initial laparotomy Must have attained a clinically defined complete remission (CR) following treatment with platinum (cisplatin or carboplatin) and paclitaxel based combination chemotherapy regimen by achieving the following: No evidence of cancer on physical examination CA-125 no greater than 35 units/mL Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Bilirubin no greater than 2.0 mg/dL Negative ascites No evidence of residual cancer on CT scan of the abdomen/pelvis or chest x-ray (or chest CT scan, if performed) No symptoms felt to be secondary to persistent malignancy Must have received a minimum of 5 and a maximum of 6 courses of chemotherapy prior to study Must register for study within 21 to 56 days after prior chemotherapy Not concurrently registered to SWOG-S9618, SWOG-S9619, SWOG-S9912, or SWOG-S0009 or front line treatment phase III GOG trials

PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other: No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antitumor treatment No concurrent immunotherapy Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Prior cisplatin allowed if initial dose at least 50 mg/m2 Prior carboplatin allowed if initial dose at least 300 mg/m2 or AUC at least 4 No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy No prior abdominal/pelvic irradiation Surgery: See Disease Characteristics No second look laparotomy or laparoscopy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003120

  Show 93 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Maurie Markman, MD The Cleveland Clinic
  More Information

Additional Information:
Publications:
Liu P, Moon J, Alberts DS, et al.: A modified CA-125 progression criterion in ovarian cancer (OC) patients (pts) receiving maintenance treatment following complete clinical response (cCR) to primary therapy. [Abstract] J Clin Oncol 24 (Suppl 18): A-5080, 275s, 2006.
Markman M, Liu P, Wilczynski S, et al.: Survival (S) of ovarian cancer (OC) patients (pts) treated on SWOG9701/GOG178: 12 versus (v) 3 cycles (C) of monthly single-agent paclitaxel (PAC) following attainment of a clinically-defined complete response (CR) to platinum (PLAT)/PAC. [Abstract] J Clin Oncol 24 (Suppl 18): A-5005, 257s, 2006.
Markman M. Maintenance chemotherapy in advanced ovarian cancer: the US experience. Int J Gynecol Cancer. 2008 Mar-Apr;18 Suppl 1:40-3.
Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460-5.
Markman M, Liu PY, Rothenberg ML, Monk BJ, Brady M, Alberts DS. Pretreatment CA-125 and risk of relapse in advanced ovarian cancer. J Clin Oncol. 2006 Mar 20;24(9):1454-8.
Liu PY, Alberts DS, Monk BJ, et al.: Relationship between pretreatment CA-125 level and risk of relapse in advanced ovarian cancer (AOC) patients in a complete clinical response (CCR) who received "maintenance therapy". [Abstract] J Clin Oncol 23 (Suppl 16): A-5013, 458s, 2005.

Study ID Numbers: CDR0000065875, SWOG-S9701, GOG-178
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003120     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Fallopian Tube Neoplasms
Recurrence
Genital Diseases, Female
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 02, 2009