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

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ClinicalTrials.gov Identifier: NCT00060359
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE May 6, 2003
First Posted Date  ICMJE May 7, 2003
Last Update Posted Date May 8, 2015
Study Start Date  ICMJE April 2003
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Feasibility, in terms of incidence of DLT, as assessed by CTC version 2.0 [ Time Frame: 84 days (first 4 courses) ]
  • Maximum tolerated dose (MTD) as assessed by CTC version 2.0 [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00060359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Incidence of cumulative toxicity [ Time Frame: 168 days (8 courses) ]
  • Pharmacokinetics and pharmacodynamics of conjugated taxanes, unconjugated paclitaxel and carboplatin, as assessed by serum and urine measurements [ Time Frame: 84 days (courses 1-4) ]
  • Progression-free survival [ Time Frame: Up to 5 years ]
  • Response [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
Official Title  ICMJE A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of CT-2103 and Carboplatin (NSC #214240) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
Brief Summary 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. 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.
Detailed Description

PRIMARY OBJECTIVES:

I. 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.

II. Determine the feasibility of this regimen at the MTD in an expanded cohort of patients.

III. Determine the response rate and progression-free survival of patients treated with this regimen in the expanded cohort.

IV. Determine the toxicity profile of this regimen in these patients. V. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fallopian Tube Carcinoma
  • Malignant Ovarian Mixed Epithelial Tumor
  • Ovarian Brenner Tumor
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Primary Peritoneal Carcinoma
  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer
  • Undifferentiated Ovarian Carcinoma
Intervention  ICMJE
  • Drug: Carboplatin
    Given IV
    Other Names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • Nealorin
    • Novoplatinum
    • Paraplat
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Drug: Paclitaxel Poliglumex
    Given IV
    Other Names:
    • CT-2103
    • Paclitaxel Polyglutamate
    • Paclitaxel-Polyglutamate Polymer
    • PG-TXL
    • Poly-L-Glutamic acid-Paclitaxel Conjugate
    • Polyglutamic Acid Paclitaxel
    • Xyotax
  • Other: Pharmacological Study
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (paclitaxel poliglumex, carboplatin)

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 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.

Interventions:
  • Drug: Carboplatin
  • Drug: Paclitaxel Poliglumex
  • Other: Pharmacological Study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2015)
32
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No active bleeding
  • 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
  • Creatinine no greater than 1.5 times ULN
  • 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
  • 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
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer (must be free of recurrent or metastatic disease)
  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00060359
Other Study ID Numbers  ICMJE GOG-9914
NCI-2012-02532 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000301642
GOG-9914 ( Other Identifier: Gynecologic Oncology Group )
GOG-9914 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mark Morgan Gynecologic Oncology Group
PRS Account Gynecologic Oncology Group
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP