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

NCT ID: NCT00060359

Last Updated: 2015-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Given IV

Paclitaxel Poliglumex

Intervention Type: DRUG

Given IV

Pharmacological Study

Intervention Type: OTHER

Correlative studies

Interventions

Carboplatin

Given IV

Intervention Type: DRUG

Paclitaxel Poliglumex

Given IV

Intervention Type: DRUG

Pharmacological Study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Blastocarb; Carboplat; Carboplatin Hexal; Carboplatino; Carbosin; Carbosol; Carbotec; CBDCA; Displata; Ercar; JM-8; Nealorin; Novoplatinum; Paraplat; Paraplatin; Paraplatin AQ; Paraplatine; Platinwas; Ribocarbo; CT-2103; Paclitaxel Polyglutamate; Paclitaxel-Polyglutamate Polymer; PG-TXL; Poly-L-Glutamic acid-Paclitaxel Conjugate; Polyglutamic Acid Paclitaxel; Xyotax

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Morgan

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02532

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000301642

Identifier Type: -

Identifier Source: secondary_id

GOG-9914

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-9914

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-9914

Identifier Type: -

Identifier Source: org_study_id