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

Primary Purpose

Fallopian Tube Carcinoma, Malignant Ovarian Mixed Epithelial Tumor, Ovarian Brenner Tumor

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel Poliglumex
Pharmacological Study
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (paclitaxel poliglumex, carboplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility, in terms of incidence of DLT, as assessed by CTC version 2.0
Maximum tolerated dose (MTD) as assessed by CTC version 2.0

Secondary Outcome Measures

Incidence of cumulative toxicity
Pharmacokinetics and pharmacodynamics of conjugated taxanes, unconjugated paclitaxel and carboplatin, as assessed by serum and urine measurements
Progression-free survival
Response

Full Information

First Posted
May 6, 2003
Last Updated
May 7, 2015
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00060359
Brief Title
Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (paclitaxel poliglumex, carboplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel Poliglumex
Other Intervention Name(s)
CT-2103, Paclitaxel Polyglutamate, Paclitaxel-Polyglutamate Polymer, PG-TXL, Poly-L-Glutamic acid-Paclitaxel Conjugate, Polyglutamic Acid Paclitaxel, Xyotax
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Feasibility, in terms of incidence of DLT, as assessed by CTC version 2.0
Time Frame
84 days (first 4 courses)
Title
Maximum tolerated dose (MTD) as assessed by CTC version 2.0
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Incidence of cumulative toxicity
Time Frame
168 days (8 courses)
Title
Pharmacokinetics and pharmacodynamics of conjugated taxanes, unconjugated paclitaxel and carboplatin, as assessed by serum and urine measurements
Time Frame
84 days (courses 1-4)
Title
Progression-free survival
Time Frame
Up to 5 years
Title
Response
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Morgan
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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