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

NCT00060359 | Completed Phase 1

• 4 other identifiers: GOG-9914NCI-2012-02532CDR0000301642U10CA027469
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Feasibility, in terms of incidence of DLT, as assessed by CTC version 2.0

  84 days (first 4 courses)

• Maximum tolerated dose (MTD) as assessed by CTC version 2.0

  21 days

Secondary Outcomes (4)

• Incidence of cumulative toxicity

  168 days (8 courses)

• Pharmacokinetics and pharmacodynamics of conjugated taxanes, unconjugated paclitaxel and carboplatin, as assessed by serum and urine measurements

  84 days (courses 1-4)

• Progression-free survival

  Up to 5 years

• Response

  Up to 5 years

Study Arms (1)

Treatment (paclitaxel poliglumex, carboplatin)

EXPERIMENTAL

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.

Drug: Carboplatin; Drug: Paclitaxel Poliglumex; Other: Pharmacological Study

Interventions

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (paclitaxel poliglumex, carboplatin)

Paclitaxel Poliglumex DRUG

Given IV

Also known as: CT-2103, Paclitaxel Polyglutamate, Paclitaxel-Polyglutamate Polymer, PG-TXL, Poly-L-Glutamic acid-Paclitaxel Conjugate, Polyglutamic Acid Paclitaxel, Xyotax

Treatment (paclitaxel poliglumex, carboplatin)

Pharmacological Study OTHER

Correlative studies

Treatment (paclitaxel poliglumex, carboplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Brenner Tumor; Ovarian Neoplasms

Interventions

Carboplatin; paclitaxel poliglumex

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Mark Morgan

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: April 1, 2003
• Primary Completion: January 1, 2009
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (1)