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Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

Phase 2
18 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

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Trial Information

Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

Patients are treated with paclitaxel intravenously every 2 weeks up to 10 courses. Patients
who achieve a complete response receive 2 additional courses those who achieve partial
response or stabilization, continue therapy until progression.

Inclusion Criteria

Inclusion Criteria

Patients must have:

- Microscopically confirmed diagnosis of KS associated with HIV for which systematic
therapy is medically indicated by the presence of at least one of the following:

A. >= 25 mucocutaneous (mouth or skin) lesions. B. Symptomatic visceral involvement. C.
Symptomatic lymphedema (pain).

- Minimum of 5 clearly measurably cutaneous lesions by physical exam or measurable
disease by X-ray, CT or MRI.

- Failed at least one systemic chemotherapy regimen.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

- Less than 2 weeks since major surgery.

- Serious uncontrolled infection. NOTE:

- Must be ruled out by thorough work-up in patients with unexplained fevers, night
sweats, or involuntary weight loss of more than 10% normal weight.

- Leukopenia.

- Thrombocytopenia.

Patients with the following prior conditions are excluded:

- History of angina or myocardial infarction within the past 6 months.

- Second degree or third degree atrioventricular block without a pacemaker.

- Congestive heart failure (poorly controlled).

- History of prior malignancy except:

Completely excised in situ, carcinoma of the cervix or nonmelanomatous skin cancer.

Curatively treated other malignancy with no evidence of disease for at least 5 years.

Prior Medication:


Prior taxane therapy.


- At least one systemic chemotherapy regimen that failed to maintain significant
benefit. NOTE:

- Intralesional chemotherapy regimens are not considered as prior chemotherapy.

- At least 2 weeks since last dose of prior systemic chemotherapy.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Paclitaxel
  • Treatment Outcome
  • Antineoplastic Agents, Phytogenic
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma



Massachusetts Gen Hosp / AIDS Oncology Research Boston, Massachusetts  02114