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Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2009
First Received: April 18, 2005   Last Updated: August 28, 2009   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00108745
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses.

In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial or peritoneal cancer or fallopian tube cancer.


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

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peripheral neuropathy by Gynecologic Oncology Group (GOG) NTX4 at 6 months after study enrollment [ Designated as safety issue: No ]
  • General quality of life by Functional Assessment of Cancer Therapy-Ovarian-Trial Outcome Index (FACT-O-TOI) at 6 months after study enrollment [ Designated as safety issue: No ]
  • Exploratory assessment of several tissue and serum angiogenic markers for prognosis by immunohistochemistry and antibody array prior to treatment in courses 1 and 2 [ Designated as safety issue: No ]
  • Exploratory time-dependent assessment of quality of life and peripheral neuropathy by FACT-O-TOI and GOG-NTX4 monthly during year 1 and then every 3 months for 2 years [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: March 2005
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.
Drug: paclitaxel poliglumex
Given IV
Arm II: Active Comparator
Patients receive paclitaxel IV over 3 hours on day 1.
Drug: paclitaxel
Given IV
Arm III: No Intervention
Patients receive no further anticancer treatment until evidence of disease progression.
Procedure: observation
No intervention

Detailed Description:

OBJECTIVES:

Primary

  • Compare overall survival of patients with stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer in clinical complete response after prior primary platinum and taxane-based chemotherapy treated with paclitaxel vs polyglutamate paclitaxel as consolidation/maintenance therapy vs no further anticancer therapy until documented disease progression.

Secondary

  • Compare progression-free survival of patients treated with these drugs.
  • Compare the toxicity profile of these drugs, particularly peripheral neuropathy, in these patients.
  • Compare the quality of life of patients treated with these drugs.

Tertiary

  • Correlate angiogenic marker expression with overall or progression-free survival of patients treated with these drugs.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.
  • Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
  • Arm III: Patients receive no further anticancer treatment until evidence of disease progression.

In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 1,110 patients (555 per treatment arm) will be accrued for this study within 8.5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer
  • The following histologic epithelial cell types are allowed:

    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner tumor
    • Adenocarcinoma not otherwise specified
  • The following histologic cell types are not allowed:

    • Germ cell tumor
    • Sex cord-stromal tumor
    • Carcinosarcoma
    • Mixed müllerian tumor or carcinosarcoma
    • Metastatic carcinoma from other sites to the ovary
    • Low malignant potential (LMP) tumor (borderline carcinoma), including micropapillary serous carcinoma

      • Patients with a prior diagnosis of LMP tumor that was surgically resected and who subsequently developed invasive adenocarcinoma are eligible provided patient did not receive prior chemotherapy for the ovarian LMP tumor
  • Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND have tissue available for histologic evaluation

    • Optimal (≤ 1 cm) residual disease OR suboptimal residual disease after initial surgery
  • Must have completed at least 5, but no more that 8 courses of primary therapy comprising carboplatin (IV or intraperitoneal) AND paclitaxel or docetaxel-based combination chemotherapy within the past 12 weeks AND have no symptoms of persistent cancer after completion of therapy

    • CT scan of the abdomen and/or pelvis normal
    • CA 125 normal
  • Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided the following criteria is met:

    • Must have undergone interval abdominal surgery after at least one but no more than 6 courses of standard chemotherapy

      • Surgery must meet the same criteria as the up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease
      • Patients must have received at least 2 courses after interval abdominal surgery
  • No synchronous primary endometrial cancer or history of primary endometrial cancer, unless all of the following criteria are met:

    • Stage ≤ IB
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No active bleeding

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • PT or PTT normal
  • No acute or chronic hepatitis

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided the disease has remained stable within the past 6 months
  • No unstable angina
  • No myocardial infarction within the past 6 months

Other

  • No neuropathy (sensory and motor) ≥ grade 2
  • No active infection requiring antibiotics
  • No ongoing gastrointestinal bleeding requiring blood product support
  • No circumstance that would preclude study participation
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy (e.g., bevacizumab or erlotinib) for any other abdominal or pelvic tumor

Chemotherapy

  • See Disease Characteristics
  • No prior polyglutamate paclitaxel
  • No prior chemotherapy for any other abdominal or pelvic tumor
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND no recurrent or metastatic disease

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin AND no recurrent or metastatic disease

Surgery

  • See Disease Characteristics

Other

  • No prior investigational therapy for any other abdominal or pelvic tumor
  • No prior anticancer therapy that would preclude study therapy
  • No concurrent amifostine or other protective agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108745

  Show 155 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Maurie Markman, MD M.D. Anderson Cancer Center
Investigator: Robert A. Burger, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group ( Philip J. DiSaia )
Study ID Numbers: CDR0000422427, GOG-0212
Study First Received: April 18, 2005
Last Updated: August 28, 2009
ClinicalTrials.gov Identifier: NCT00108745     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer
ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian mucinous cystadenocarcinoma
ovarian serous cystadenocarcinoma
Brenner tumor
ovarian undifferentiated adenocarcinoma
fallopian tube cancer

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

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 03, 2009