Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

This study has been completed.
Sponsor:
Collaborators:
CTI BioPharma
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00060359
First received: May 6, 2003
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

RATIONALE: Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with carboplatin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: carboplatin
Drug: paclitaxel poliglumex
Procedure: adjuvant therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: An Expanded Cohort Phase I Study Of CT-2103 (IND #61013) And Carboplatin In Patients With Previously Untreated Epithelial Ovarian Carcinoma Or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) as assessed by CTC version 2.0 during the first course of therapy [ Designated as safety issue: Yes ]
  • Feasibility as assessed by CTC version 2.0 weekly during treatment for up to 8 courses [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rates as measured by RECIST criteria after courses 4 and 8 [ Designated as safety issue: No ]
  • Pharmacokinetics as assessed by serum and urine measurements during courses 1-4 [ Designated as safety issue: No ]

Study Start Date: April 2003
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of polyglutamate paclitaxel in combination with carboplatin in patients with chemotherapy-naïve ovarian epithelial, primary peritoneal, or fallopian tube carcinoma.
  • Determine the feasibility of this regimen at the MTD in an expanded cohort of patients.
  • Determine the response rate and progression-free survival of patients treated with this regimen in the expanded cohort.
  • Determine the toxicity profile of this regimen in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this drug combination in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study of polyglutamate paclitaxel (CT-2103) followed by a feasibility, multicenter study.

  • Dose-escalation phase: Patients receive CT-2103 IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CT-2103 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of treatment.

  • Feasibility phase: Once the MTD of CT-2103 is determined, an additional 20-40 patients receive treatment at that dose level combined with carboplatin as above.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for dose-escalation phase and 20-40 for feasibility phase) will be accrued for this study within 4-10 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma

    • Stage III or IV
    • Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
  • The following histologic epithelial cell types are eligible:

    • Serous adenocarcinoma
    • Mucinous adenocarcinoma
    • Clear cell adenocarcinoma
    • Transitional cell carcinoma
    • Adenocarcinoma not otherwise specified
    • Endometrioid adenocarcinoma
    • Undifferentiated carcinoma
    • Mixed epithelial carcinoma
    • Malignant Brenner tumor
  • No epithelial tumors of low malignant potential (borderline tumors)
  • Surgery performed within the past 12 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastasis)
  • Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastasis)
  • No acute hepatitis
  • PT and PTT normal

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for the past 6 months
  • No myocardial infarction within the past 6 months
  • No unstable angina

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No neuropathy (sensory or motor) grade 2 or worse
  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or localized breast cancer
  • No active infection requiring antibiotics
  • No circumstances that would preclude study completion or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer (must be free of recurrent or metastatic disease)

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

  • See Disease Characteristics

Other

  • No prior treatment, other than debulking surgery, for this cancer
  • No prior treatment for another cancer that would contraindicate this protocol therapy
  • No concurrent amifostine or other protective reagents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060359

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden, New Jersey, United States, 08103
United States, Ohio
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Gynecologic Oncology Group
CTI BioPharma
Investigators
Study Chair: Mark A. Morgan, MD, FACOG, FACS Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00060359     History of Changes
Other Study ID Numbers: GOG-9914, CDR0000301642, NCI-2012-02532
Study First Received: May 6, 2003
Last Updated: August 19, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Adminstration
United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian mucinous cystadenocarcinoma
ovarian serous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
Brenner tumor
fallopian tube cancer
primary peritoneal cavity cancer

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

ClinicalTrials.gov processed this record on September 30, 2014