DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theradex
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed carcinoma of the pancreas

• Metastatic disease

• Measurable disease

• Lesions within a previously irradiated field are not considered measurable

• No islet cell tumors, lymphoma, or sarcoma of the pancreas

• No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT or SGPT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled ventricular arrhythmia

• No myocardial infarction within the past 3 months

• No superior vena cava syndrome

Neurologic:

• No peripheral neuropathy greater than grade 1

• No uncontrolled major seizure disorder

• No spinal cord compression

Other:

• No concurrent serious infection requiring parenteral therapy

• No unstable or serious concurrent medical condition

• No other prior malignancy except:

• Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR

• Other cancer curatively treated with surgery alone that has not recurred for more than 5 years

• No psychiatric disorder that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior chemotherapy for metastatic disease

• Prior adjuvant chemoradiotherapy allowed

• At least 28 days since prior chemotherapy and recovered

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except megestrol

Radiotherapy:

• See Disease Characteristics

• Prior adjuvant chemoradiotherapy allowed

• At least 28 days since prior large-field radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• At least 14 days since prior major surgery and recovered

Other:

• No other concurrent anticancer therapy