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

Sponsor

Roswell Park Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00003569

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

0.7

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Lung Cancer Neurotoxicity Ovarian Cancer	Drug: cisplatin Drug: dimesna Drug: paclitaxel

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

2 participants

Official Title:

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

Study Start Date :

Mar 1, 1998

Actual Primary Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
2	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
3	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001