Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel

Lung Cancer Clinical Trial

Official title:

Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003569
• Other study ID #: DS 97-39
• Secondary ID: RPCI-DS-9739BION
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: January 30, 2013
• Start date: March 1998

Study information

• Verified date: January 2013
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as dimesna may protect normal cells from the side effects of chemotherapy.

PURPOSE: This phase I trial is studying the side effects and best dose of dimesna in treating patients with solid tumors who are receiving cisplatin and paclitaxel.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose (MTD) of dimesna administered prior to cisplatin and paclitaxel in patients with solid tumors.

• Determine the dose related qualitative and quantitative side effects of dimesna administered on this schedule in these patients.

• Determine the minimum safe volume of intravenous hydration after the determination of the MTD of dimesna in these patients.

• Investigate the possible protective side effects of dimesna in reducing or preventing the development of cisplatin induced nephrotoxicity and observe possible protective effects against cisplatin or paclitaxel related neurotoxicity and myelosuppression in these patients.

• Investigate the pharmacokinetic behavior of dimesna in the plasma and urine on this schedule of administration in this patient population.

OUTLINE: This is a dose-escalation, two-stage, multicenter study.

During stage I, patients receive a single dose of dimesna IV over 15 minutes 7 days prior to chemotherapy. Patients then receive paclitaxel IV over 3 hours followed by dimesna IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour on day 1 every 3 weeks. Patients continue courses of paclitaxel, dimesna, and cisplatin every 3 weeks in the absence of disease progression or unacceptable toxicity for up to 6 courses.

In stage I, cohorts of 3-6 patients each receive escalating doses of dimesna until the maximum tolerated dose (MTD) is reached. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT). The MTD of dimesna is then used in stage II of the study, in which the volume of pre and post cisplatin intravenous saline hydration is reduced in cohorts of 3-6 patients each. The MTD intensity of cisplatin is defined as the least saline hydration volume at which no more than 1 of 6 patients experience DLT.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued into this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer, ovarian carcinoma, squamous cell carcinoma of the head and neck, tumor types for which no standard treatment exists, or tumor types that have failed standard therapy

• Paclitaxel and cisplatin combination therapy must be an appropriate option in treating disease

• No potentially curable type of cancer (e.g., newly diagnosed testicular cancer)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 6 weeks

Hematopoietic:

• WBC greater than 4,000/mm^3

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin normal

• SGOT and SGPT normal

Renal:

• Creatinine normal

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No evidence of congestive heart failure

• No uncontrolled moderate to severe hypertension

• Includes patients with persistent elevated systolic blood pressures of greater than 170 mm Hg and diastolic blood pressures of greater than 100 mm Hg for more than 1 month while under medical treatment

Other:

• No active infection

• No perceived or actual clinical risk of cisplatin induced toxicity that exceeds the clinical benefit of using cisplatin therapy

• No known history of severe hypersensitivity to polyoxyl 35 castor oil vehicle

• No severe medical problems unrelated to malignancy that would interfere with compliance in this study

• Not pregnant

• Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent colony stimulating factors except for febrile neutropenia

• No concurrent aminoglycoside therapy except for febrile neutropenia or other life threatening infections

• No concurrent immunotherapy

Chemotherapy:

• At least 6 weeks since prior nitrosoureas or mitomycin

• At least 3 weeks since other prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to measurable disease

Surgery:

• At least 2 weeks since prior major surgery

Other:

• No other concurrent investigational agents

Study Design

N/A

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Neurotoxicity
• Neurotoxicity Syndromes
• Ovarian Cancer

Intervention

Drug:
• cisplatin

• dimesna

• paclitaxel

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Chicago Cancer Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,